Compositions and methods to inhibit kidney stone growth

ABSTRACT

An oral dosage form or plurality of oral dosage forms comprising as active ingredients combinations of citric acid, magnesium citrate, phytin, pyridoxine, and musa is disclosed. The oral dosage form(s) is useful for inhibiting calcium oxalate crystal growth and for treating or inhibiting growth of kidney stones. Methods of inhibiting calcium oxalate crystal growth and of treating or preventing kidney stones are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/487,735, filed Apr. 14, 2017, which is a continuation of U.S.application Ser. No. 15/266,464, filed Sep. 15, 2016, now issued as U.S.Pat. No. 9,623,066, which is a divisional of U.S. application Ser. No.15/059,644, filed Mar. 3, 2016 and now issued as U.S. Pat. No.9,492,491, which is a continuation-in-part of U.S. application Ser. No.14/960,692, filed Dec. 7, 2015, which is a continuation application ofU.S. application Ser. No. 14/845,612, filed Sep. 4, 2015, now issued asU.S. Pat. No. 9,233,135, each of which is incorporated herein byreference in its entirety.

FIELD OF INVENTION

The disclosure relates to novel compositions comprised of active agentsincluding vitamins, minerals, and food additives ingredients to preventand treat kidney stone formation and promote overall improved kidneyhealth for patients that may be susceptible to forming stones in thekidney, renal pelvis, ureter, bladder, or all other renal genitourinaryareas.

BACKGROUND

Kidney stones, also called renal calculi, are solid crystal aggregationsof dissolved minerals in urine. Depending on their location in theurinary tract these calculi are called by various names, e.g., kidneystones, ureteric stones, bladder stones, or urethral stones. Most kidneystones are caused by the precipitation of calcium in the form of calciumoxalate. A minority of stones may also be caused by or includeprecipitated calcium hydroxyl phosphate (apatite), magnesium ammoniumphosphate (struvite), uric acid, or cysteine. In addition toexcruciating pain, symptoms of kidney stones may also include blood inthe urine due to minor damage to inside lining of kidney, ureter, andurethra; reduced urine volume caused by obstruction of the bladder orurethra by the stones; kidney infection as a result of stone blockage;abdominal distention; nausea or vomiting; and fever and chills.

Kidney stone disease is an ailment afflicting human kind for manycenturies. It can affect up to a quarter of the population in certaingeographic areas and hence poses a significant health problem.Approximately 85% of the stones in human are calcium stones comprisingoxalate and phosphate, either alone or combined. The pathogenesis ofcalcium oxalate stone formation is a multi-step process and in essenceincludes—nucleation, crystal growth, crystal aggregation, and crystalretention. Various substances in the body have an effect on one or moreof the above stone forming processes, thereby influencing a person'sability to promote or prevent stone formation. Low urine volume, lowurine pH, calcium, sodium, oxalate, and urate are known to promote stoneformation. Many inorganic (e.g., magnesium) and organic (e.g., urinaryprothrombin fragment 1, glycosaminoglycans, osteopontin, citrate)substances are known to inhibit stone formation.

The initiation of growth of a calcium oxalate stone is thought to occurat sites of inflammation or damage within the kidney. The stones form byan initial deposition of calcium crystals at the sites of inflammationor damage and are known in the literature as Randall's plaques. TheseRandall's plaques then serve as nuclei for formation of calcium oxalateon top of the calcium hydroxyapatite mini-stones. Once of a certainsize, stones often fragment or a break off from the Randall plaqueregion and can either pass out of the body or get stuck along theurinary tract, resulting in clinical symptoms such as reduced urineflow, pain or bleeding.

Prevalence of kidney stones in the United States has been estimated at8.8% (roughly 1 in 11 people). Among men, the prevalence of stones was10.6%, compared with 7.1% among women. Kidney stones were more commonamong obese than normal-weight individuals. (Eur Urol. 2012 July;62(1):160-5.)

Reoccurrence of stones in patients has been estimated to be as high as50 percent within 5 years of the initial event. Rates of emergencydepartment visits for kidney stone disease have increased 20 percentbetween 2005 and 2009.

In 2014, one study suggested that kidney stone interventions cost anestimated $10 billion annually in the United States and patients whohave an unplanned hospital visit for kidney stones incur average costsof nearly $30,000, depending on the type of procedure and the subsequentcare. (Duke University Medical Center. “Complications from kidney stonetreatments are common, costly.” ScienceDaily. 28 Apr. 2014)

Medical treatment options depend on severity of pain, size of stone, andlocation of stone. Smaller stones will often pass on their own. Forlarger stones, some form of intervention is usually required andinclude: ureteroscopy and laser stone lithotripsy (the stone is locatedwith a small camera inserted into the urethra and removed with a smallbasket or broken up with a laser); extracorporeal shockwave lithotripsy(ESWL; breaks up stone from the outside of the body with shockwaves thattravel through a gel-like medium); Percutaneous Nephrolithotomy (PCNL;inpatient procedure for very large stones, which typically requires anovernight hospital stay). If patient has more than one kidney stone orstone occurrence, physician often recommends getting a special urinestudy done. A 24-hour urine study will show the composition of urine inrelation to kidney stone formation. Diet can be altered or improvedbased on these results to help in preventing reoccurrence of a stone.Rarely patients are placed on a prescription medication as the optionsare very limited and can have serious side effects or risks for thepatient. Sometimes pain medications are utilized as the stone is passingthrough the person's system. One goal in diet alteration is to try toprevent crystal formation. Common recommendations include: drink morewater, often at least 6-8 glasses per day; decrease caffeine intake;eliminate colas due to phosphoric acid content; drink lemon water;decrease sodium, sugar, and red meat and oxalate-rich foods (e.g.,Spinach, strawberries, nuts, tea); and increase fiber intake.

Various active agents are known to have an effect on kidney stones,including citric acid, magnesium citrate, phytin, pyridoxine, and musa,however, these active agents have not been combined in one composition,nor have they been combined in amounts that maximize the percentinhibition of crystal formation.

Thus, there remains a need for a simple and effective method andcomposition for preventing and treating kidney stones that optimizes theinhibition of crystal formation.

SUMMARY

Disclosed is a novel oral dosage form or a plurality of oral dosageforms.

In an embodiment, the oral dosage form or plurality of oral dosage formscomprises as active ingredients citric acid, magnesium citrate, phytin,pyridoxine, and musa.

In an embodiment, the oral dosage form or plurality of oral dosage formscomprises as active ingredients citric acid, magnesium citrate, phytin,and pyridoxine.

In an embodiment, the oral dosage form or plurality of oral dosage formscomprises as active ingredients citric acid, magnesium citrate, phytin,and musa.

In an embodiment, the oral dosage form or plurality of oral dosage formscomprises as active ingredients citric acid, magnesium citrate,pyridoxine, and musa.

In an embodiment, the oral dosage form or plurality of oral dosage formscomprises as active ingredients citric acid, phytin, pyridoxine, andmusa.

In an embodiment, the oral dosage form or plurality of oral dosage formscomprises as active ingredients magnesium citrate, phytin, pyridoxine,and musa

Also disclosed is a method of treating and/or inhibiting growth ofkidney stones.

In an embodiment, the method comprises administering to a patient inneed thereof the oral dosage form or plurality of dosage forms disclosedherein.

In an embodiment, the method comprises administering to a patient inneed thereof about 101 mg to about 700 mg citric acid; about 76 mg toabout 226 mg magnesium citrate; about 3 mg to about 600 mg phytin; about0.1 mg to about 15 mg pyridoxine; and about 1 mg to about 251 mg musa.

Also disclosed is a method of inhibiting growth of calcium oxalatecrystals.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with the oral dosage form or plurality ofdosage forms disclosed herein.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with a composition comprising as activeingredients citric acid, magnesium citrate, phytin, pyridoxine, andmusa.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with a composition comprising as activeingredients citric acid, magnesium citrate, phytin, and pyridoxine.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with a composition comprising as activeingredients citric acid, magnesium citrate, phytin, and musa.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with a composition comprising as activeingredients citric acid, magnesium citrate, pyridoxine, and musa.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with a composition comprising as activeingredients citric acid, phytin, pyridoxine, and musa.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with a composition comprising as activeingredients magnesium citrate, phytin, pyridoxine, and musa.

These and other advantages, as well as additional inventive features,will be apparent from the following Drawings, Detailed Description,Examples, and Claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The following is a brief description of the drawings which are presentedfor the purposes of illustrating the exemplary embodiments disclosedherein and not for the purposes of limiting the same.

FIG. 1 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Test Solution 1.

FIG. 2 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with TestSolution 1.

FIG. 3 is a graph showing absorbance at 620.6 nm as a function of timefor Test Solution 1.

FIG. 4 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Test Solution 1.

FIG. 5 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Test Solution 2.

FIG. 6 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with TestSolution 2.

FIG. 7 is a graph showing absorbance at 620.6 nm as a function of timefor Test Solution 2.

FIG. 8 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Test Solution 2.

FIG. 9 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Test Solution 3.

FIG. 10 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with TestSolution 3.

FIG. 11 is a graph showing absorbance at 620.6 nm as a function of timefor Test Solution 3.

FIG. 12 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Test Solution 3.

FIG. 13 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Test Solution 4.

FIG. 14 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with TestSolution 4.

FIG. 15 is a graph showing absorbance at 620.6 nm as a function of timefor Test Solution 4.

FIG. 16 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Test Solution 4.

FIG. 17 is a graph showing absorbance at 620.6 nm as a function of timesfor Control Vehicle Runs Associated with Test Solution 5.

FIG. 18 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Vehicle Runs Associated with Test Solution 5.

FIG. 19 is a graph showing absorbance at 620.6 nm as a function of timefor Test Solution 5.

FIG. 20 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Test Solution 5.

FIG. 21 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Test Solution 6.

FIG. 22 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with TestSolution 6.

FIG. 23 is a graph showing absorbance at 620.6 nm as a function of timefor Test Solution 6.

FIG. 24 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Test Solution 6.

FIG. 25 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Test Solution 7 (Repeat of TestSolution 1).

FIG. 26 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with TestSolution 7 (Repeat of Test Solution 1).

FIG. 27 is a graph showing absorbance at 620.6 nm as a function of timefor Test Solution 7 (Repeat of Test Solution 1).

FIG. 28 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Test Solution 7 (Repeat of Test Solution 1).

FIG. 29 is a histogram showing median and mean inhibition of calciumoxalate crystal formation by Test Solutions 1-6.

FIG. 30 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 1 for Test Solution 1.

FIG. 31 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 1for Test Solution 1.

FIG. 32 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 1 for Test Solution 1.

FIG. 33 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 1 for Test Solution 1.

FIG. 34 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 1 for Test Solution 2.

FIG. 35 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 1for Test Solution 2.

FIG. 36 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 1 for Test Solution 2.

FIG. 37 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 1 for Test Solution 2.

FIG. 38 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 1 for Test Solution 3.

FIG. 39 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 1for Test Solution 3.

FIG. 40 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 1 for Test Solution 3.

FIG. 41 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 1 for Test Solution 3.

FIG. 42 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 1 for Test Solution 4.

FIG. 43 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 1for Test Solution 4.

FIG. 44 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 1 for Test Solution 4.

FIG. 45 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 1 for Test Solution 4.

FIG. 46 is a graph showing absorbance at 620.6 nm as a function of timesfor Control Vehicle Runs Associated with Matrix 1 for Test Solution 5.

FIG. 47 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Vehicle Runs Associated with Matrix 1 forTest Solution 5.

FIG. 48 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 1 for Test Solution 5.

FIG. 49 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 1 for Test Solution 5.

FIG. 50 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 1 for Test Solution 6.

FIG. 51 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 1for Test Solution 6.

FIG. 52 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 1 for Test Solution 6.

FIG. 53 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 1 for Test Solution 6.

FIG. 54 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 2 for Test Solution 1.

FIG. 55 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 2for Test Solution 1.

FIG. 56 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 2 for Test Solution 1.

FIG. 57 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 2 for Test Solution 1.

FIG. 58 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 2 for Test Solution 2.

FIG. 59 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 2for Test Solution 2.

FIG. 60 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 2 for Test Solution 2.

FIG. 61 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 2 for Test Solution 2.

FIG. 62 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 2 for Test Solution 3.

FIG. 63 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 2for Test Solution 3.

FIG. 64 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 2 for Test Solution 3.

FIG. 65 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 2 for Test Solution 3.

FIG. 66 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 2 for Test Solution 4.

FIG. 67 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 2for Test Solution 4.

FIG. 68 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 2 for Test Solution 4.

FIG. 69 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 2 for Test Solution 4.

FIG. 70 is a graph showing absorbance at 620.6 nm as a function of timesfor Control Vehicle Runs Associated with Matrix 2 for Test Solution 5.

FIG. 71 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Vehicle Runs Associated with Matrix 2 forTest Solution 5.

FIG. 72 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 2 for Test Solution 5.

FIG. 73 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 2 for Test Solution 5.

FIG. 74 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 2 for Test Solution 6.

FIG. 75 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 2for Test Solution 6.

FIG. 76 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 2 for Test Solution 6.

FIG. 77 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 2 for Test Solution 6.

FIG. 78 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 3 for Test Solution 1.

FIG. 79 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 3for Test Solution 1.

FIG. 80 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 3 for Test Solution 1.

FIG. 81 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 3 for Test Solution 1.

FIG. 82 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 3 for Test Solution 2.

FIG. 83 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 3for Test Solution 2.

FIG. 84 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 3 for Test Solution 2.

FIG. 85 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 3 for Test Solution 2.

FIG. 86 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 3 for Test Solution 3.

FIG. 87 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 3for Test Solution 3.

FIG. 88 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 3 for Test Solution 3.

FIG. 89 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 3 for Test Solution 3.

FIG. 90 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 3 for Test Solution 4.

FIG. 91 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 3for Test Solution 4.

FIG. 92 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 3 for Test Solution 4.

FIG. 93 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 3 for Test Solution 4.

FIG. 94 is a graph showing absorbance at 620.6 nm as a function of timesfor Control Vehicle Runs Associated with Matrix 3 for Test Solution 5.

FIG. 95 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Vehicle Runs Associated with Matrix 3 forTest Solution 5.

FIG. 96 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 3 for Test Solution 5.

FIG. 97 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 3 for Test Solution 5.

FIG. 98 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 3 for Test Solution 6.

FIG. 99 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 3for Test Solution 6.

FIG. 100 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 3 for Test Solution 6.

FIG. 101 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 3 for Test Solution 6.

FIG. 102 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 4 for Test Solution 1.

FIG. 103 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 4for Test Solution 1.

FIG. 104 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 4 for Test Solution 1.

FIG. 105 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 4 for Test Solution 1.

FIG. 106 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 4 for Test Solution 2.

FIG. 107 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 4for Test Solution 2.

FIG. 108 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 4 for Test Solution 2.

FIG. 109 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 4 for Test Solution 2.

FIG. 110 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 4 for Test Solution 3.

FIG. 111 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 4for Test Solution 3.

FIG. 112 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 4 for Test Solution 3.

FIG. 113 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 4 for Test Solution 3.

FIG. 114 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 4 for Test Solution 4.

FIG. 115 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 4for Test Solution 4.

FIG. 116 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 4 for Test Solution 4.

FIG. 117 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 4 for Test Solution 4.

FIG. 118 is a graph showing absorbance at 620.6 nm as a function oftimes for Control Vehicle Runs Associated with Matrix 4 for TestSolution 5.

FIG. 119 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Vehicle Runs Associated with Matrix 4 forTest Solution 5.

FIG. 120 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 4 for Test Solution 5.

FIG. 121 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 4 for Test Solution 5.

FIG. 122 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 4 for Test Solution 6.

FIG. 123 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 4for Test Solution 6.

FIG. 124 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 4 for Test Solution 6.

FIG. 125 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 4 for Test Solution 6.

FIG. 126 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 5 for Test Solution 1.

FIG. 127 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 5for Test Solution 1.

FIG. 128 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 5 for Test Solution 1.

FIG. 129 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 5 for Test Solution 1.

FIG. 130 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 5 for Test Solution 2.

FIG. 131 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 5for Test Solution 2.

FIG. 132 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 5 for Test Solution 2.

FIG. 133 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 5 for Test Solution 2.

FIG. 134 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 5 for Test Solution 3.

FIG. 135 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 5for Test Solution 3.

FIG. 136 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 5 for Test Solution 3.

FIG. 137 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 5 for Test Solution 3.

FIG. 138 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 5 for Test Solution 4.

FIG. 139 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 5for Test Solution 4.

FIG. 140 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 5 for Test Solution 4.

FIG. 141 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 5 for Test Solution 4.

FIG. 142 is a graph showing absorbance at 620.6 nm as a function oftimes for Control Vehicle Runs Associated with Matrix 5 for TestSolution 5.

FIG. 143 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Vehicle Runs Associated with Matrix 5 forTest Solution 5.

FIG. 144 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 5 for Test Solution 5.

FIG. 145 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 5 for Test Solution 5.

FIG. 146 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 5 for Test Solution 6.

FIG. 147 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 5for Test Solution 6.

FIG. 148 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 5 for Test Solution 6.

FIG. 149 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 5 for Test Solution 6.

FIG. 150 is a graph showing absorbance at 620.6 nm as a function of timefor Control Vehicle Runs Associated with Matrix 5 for Test Solution 7.

FIG. 151 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Control Vehicle Runs Associated with Matrix 5for Test Solution 7.

FIG. 152 is a graph showing absorbance at 620.6 nm as a function of timefor Matrix 5 for Test Solution 7.

FIG. 153 is a graph showing absorbance at 620.6 nm as a function of timeto determine the Slope for Matrix 5 for Test Solution 7.

DETAILED DESCRIPTION

A novel oral dosage form or a plurality of oral dosage forms comprisingthe ingredients citric acid, magnesium citrate, phytin, pyridoxine, andmusa is disclosed herein. The disclosed oral dosage form or plurality ofdosage forms is useful for treating and/or inhibiting growth of kidneystones. Methods of using the oral dosage form or plurality of dosageforms to treat or inhibit growth of kidney stones are also disclosed.

Although there is some clinical evidence that each of these ingredientsindividually plays a role in preventing or treating kidney stones, allfive ingredients have never previously been combined in one formulationor dosing regimen for treating or inhibiting formation of kidney stones.In addition, combinations containing four of these ingredients havenever been combined in one formulation or dosing regimen for treating orinhibiting formation of kidney stones.

Surprisingly, not all concentration ranges of the active ingredients inthe combination provide effective inhibition of kidney stones or calciumoxalate growth. In particular, we have discovered preferred ranges inthe combination of the five active ingredients that maximize the percentinhibition of kidney stones and more particularly calcium oxalatecrystal growth, resulting in mean percent inhibition of the calciumoxalate crystal growth of at least about 92%. Compositions of the fiveactive ingredients having concentrations outside the preferred rangesare unexpectedly much less effective in inhibiting calcium oxalatecrystal growth. In addition, we have discovered preferred ranges incombinations containing four of the five active ingredients thatmaximize the percent inhibition of kidney stones and more particularlycalcium oxalate crystal growth. Compositions containing four of the fiveactive ingredients having concentrations outside the preferred rangesare unexpectedly much less effective in inhibiting calcium oxalatecrystal growth.

For a dosage form or plurality of dosage forms containing all fiveingredients, a preferred range for citric acid is about 101 mg to about700 mg; and more preferably about 101 mg to about 352 mg, about 101 mgto about 176 mg, about 176 mg to about 700 mg, or about 352 mg to about700 mg. A preferred range for magnesium citrate is about 76 mg to about226 mg; and more preferably about 76 mg to about 201 mg, about 76 mg toabout 150 mg, about 150 to about 226 mg, or about 201 mg to about 226mg. A preferred range for phytin is about 3 mg to about 600 mg; morepreferably about 3 mg to about 400 mg, about 3 mg to about 202 mg, about3 mg to about 100 mg, about 100 mg to about 600 mg, about 201 mg toabout 600 mg, or about 400 mg to about 600 mg. A preferred range forpyridoxine is about 0.2 mg to about 15 mg; more preferably about 0.2 mgto about 10.1 mg, about 0.2 mg to about 6 mg, about 0.2 mg to about 2.7mg, about 2.7 mg to about 15 mg, about 6.0 mg to about 15 mg, or about10 mg to about 15 mg. A preferred range for musa is about 1 mg to about251 mg; more preferably about 1 mg to about 167 mg, about 1 mg to about85 mg, about 1 mg to about 41 mg, about 41 mg to about 251 mg, about 85mg to about 251 mg, or about 167 mg to about 251 mg.

Most preferred is an oral dosage form or a plurality of dosage formscomprising citric acid, magnesium citrate, phytin, pyridoxine, and musawhere citric acid is present in an amount of about 350 mg, magnesiumcitrate is present in an amount of about 150 mg, phytin is present in anamount of about 200 mg, pyridoxine is present in an amount of about 5mg, and musa is present in amount of about 250 mg.

For a dosage form or plurality of dosage forms containing citric acid,magnesium citrate, phytin, and pyridoxine, a preferred range for citricacid is about 101 mg to about 699 mg, magnesium citrate is about 77 mgto about 227 mg, phytin is about 3.06 mg to about 600 mg, and pyridoxineabout 0.23 mg to about 15.13.

More preferably for a dosage form or plurality of dosage formscontaining citric acid, magnesium citrate, phytin, and pyridoxine,citric acid is present in an amount selected from: about 101 mg to about354 mg, about 101 mg to about 178 mg, about 178 mg to about 699 mg,about 178 mg to about 354 mg, and about 352 mg to about 699 mg;magnesium citrate is present in an amount selected from: about 77 mg toabout 202 mg, about 77 mg to about 151 mg, about 151 to about 227 mg,about 151 to about 202 mg, and about 202 mg to about 227 mg; phytin ispresent in an amount selected from: about 3.06 mg to about 400 mg, about3.06 mg to about 201 mg, about 3.06 mg to about 100 mg, about 100 mg toabout 600 mg, about 100 mg to about 400 mg, about 100 mg to about 201mg, about 201 mg to about 600 mg, about 201 mg to about 400 mg, andabout 400 mg to about 600 mg; and pyridoxine is present in an amountselected from: about 0.23 mg to about 10.67 mg, about 0.23 mg to about5.95 mg, about 0.23 mg to about 2.68 mg, about 2.68 mg to about 15.13mg, about 2.68 mg to about 10.67 mg, about 2.68 mg to about 5.95 mg,about 5.45 mg to about 15.13 mg, about 5.45 mg to about 10.67 mg, andabout 10.67 mg to about 15.13 mg.

Most preferred for a dosage form or plurality of dosage forms containingcitric acid, magnesium citrate, phytin, and pyridoxine is one in whichcitric acid is present in an amount of about 350 mg, magnesium citrateis present in an amount of about 150 mg, phytin is present in an amountof about 200 mg, and pyridoxine is present in an amount of about 5 mg.

For a dosage form or plurality of dosage forms containing citric acid,magnesium citrate, phytin, and musa, a preferred range for citric acidis about 102 mg to about 1052 mg, magnesium citrate is about 2.32 mg toabout 201 mg, phytin is about 100 mg to about 600 mg, and musa is about1.51 mg to about 251 mg.

More preferably for a dosage form or plurality of dosage formscontaining citric acid, magnesium citrate, phytin, and musa, citric acidis present in an amount selected from: about 102 mg to about 700 mg,about 102 mg to about 352 mg, about 102 mg to about 177 mg, about 177 mgto about 1052 mg, about 177 mg to about 700 mg, about 177 mg to about352 mg, about 351 mg to about 1052 mg, about 351 mg to about 700 mg, andabout 700 mg to about 1052 mg; magnesium citrate is present in an amountselected from: about 2.32 mg to about 201 mg, about 2.32 mg to about 151mg, about 2.32 to about 77 mg, about 77 to about 201 mg, about 77 toabout 151 mg, and about 150 mg to about 201 mg; phytin is present in anamount selected from: about 100 mg to about 401 mg, about 100 mg toabout 202 mg, about 201 mg to about 600 mg, about 201 mg to about 401mg, and about 401 mg to about 600 mg; and musa is present in an amountselected from: about 1.51 mg to about 167 mg, about 1.51 mg to about 86mg, about 1.51 mg to about 41 mg, about 41 mg to about 251 mg, about 41mg to about 167 mg, about 41 mg to about 86 mg, about 86 mg to about 251mg, about 86 mg to about 167, and about 167 mg to about 251 mg.

Most preferred is an oral dosage form or a plurality of dosage formscontaining citric acid, magnesium citrate, phytin, and musa where citricacid is present in an amount of about 350 mg, magnesium citrate ispresent in an amount of about 150 mg, phytin is present in an amount ofabout 200 mg, and musa is present in amount of about 250 mg.

For a dosage form or plurality of dosage forms containing citric acid,magnesium citrate, pyridoxine, and musa, a preferred range for citricacid is about 101 mg to about 1051 mg, magnesium citrate is 2.14 mg toabout 226 mg, pyridoxine is 0.25 mg to about 10.23 mg, and musa is about41.02 mg to about 252 mg.

More preferably for a dosage form or plurality of dosage formscontaining citric acid, magnesium citrate, pyridoxine, and musa, citricacid is present in an amount selected from: about 101 mg to about 700mg, about 101 mg to about 353 mg, about 101 mg to about 176 mg, about176 mg to about 1051 mg, about 176 mg to about 700 mg, about 176 mg toabout 353 mg, about 352 mg to about 1051 mg, about 352 mg to about 700mg, and about 700 mg to about 1051 mg; magnesium citrate is present inan amount selected from: about 2.14 mg to about 202 mg, about 2.14 mg toabout 153 mg, about 2.14 mg to about 77 mg, about 77 to about 226 mg,about 77 to about 202 mg, about 77 to about 153 mg, about 151 mg toabout 226 mg, about 151 mg to about 202 mg, and about 202 mg to about226 mg; pyridoxine is present in an amount selected from: about 0.25 mgto about 5.95 mg, about 0.25 mg to about 2.63 mg, about 2.63 mg to about10.23 mg, about 2.63 mg to about 5.95 mg, and about 5.41 mg to about10.23 mg; and musa is present in an amount selected from: about 41.02 mgto about 167 mg, about 41.02 mg to about 85 mg, about 85 mg to about 252mg, about 85 mg to about 167 mg, and about 167 mg to about 252 mg.

Most preferred is an oral dosage form or a plurality of dosage formscomprising citric acid, magnesium citrate, pyridoxine, and musa wherecitric acid is present in an amount of about 350 mg, magnesium citrateis present in an amount of about 150 mg, pyridoxine is present in anamount of about 5 mg, and musa is present in an amount of about 250 mg.

For a dosage form or plurality of dosage forms containing citric acid,phytin, pyridoxine, and musa a preferred range for citric acid is about101 mg to less than about 700 mg, phytin is about 101 mg to about 600mg, pyridoxine is about 0.23 mg to about 15.12 mg, and musa is about1.46 mg to about 252 mg.

More preferably for a dosage form or plurality of dosage formscontaining citric acid, phytin, pyridoxine, and musa, citric acid ispresent in an amount selected from: about 101 mg to about 353 mg, about101 mg to about 177 mg, about 177 mg to less than about 700 mg, about177 mg to about 353 mg, and about 352 mg to less than about 700 mg;phytin is present in an amount selected from: about 101 mg to about 400mg, about 101 mg to about 203 mg, about 202 mg to about 600 mg, about202 to about 400 mg, and about 400 to about 600 mg; pyridoxine ispresent in an amount selected from: about 0.23 mg to about 10.20 mg,about 0.23 mg to about 6.00 mg, about 0.23 mg to about 2.69 mg, about2.69 mg to about 15.12 mg, about 2.69 mg to about 10.20 mg, about 2.69mg to about 6.00 mg, about 5.45 mg to about 15.12 mg, about 5.45 mg toabout 10.20 mg, and about 10.20 mg to about 15.12 mg; and musa ispresent in an amount selected from: about 1.46 mg to about 167 mg, about1.46 mg to about 86 mg, about 1.46 mg to about 41 mg, about 41 mg toabout 252 mg, about 41 mg to about 167 mg, about 41 mg to about 86 mg,about 86 mg to about 252 mg, about 86 mg to about 167 mg, and about 167mg to about 252 mg.

Most preferred is an oral dosage form or a plurality of dosage formscontaining citric acid, phytin, pyridoxine, and musa where citric acidis present in an amount of about 350 mg, phytin is present in an amountof about 200 mg, pyridoxine is present in an amount of about 5 mg, andmusa is present in amount of about 250 mg.

For a dosage form or plurality of dosage forms containing magnesiumcitrate, phytin, pyridoxine, and musa a preferred range for magnesiumcitrate is about 2.03 mg to about 203 mg, phytin is about 100 mg toabout 600 mg, pyridoxine is about 0.22 mg to about 15.1 mg, and musa isabout 1.46 mg to about 252 mg.

More preferably for a dosage form or plurality of dosage formscontaining magnesium citrate, phytin, pyridoxine, and musa, magnesiumcitrate is present in an amount selected from: about 2.03 mg to about 77mg, about 2.03 mg to about 151 mg, about 77 mg to about 151 mg, about 77mg to about 203 mg, and about 151 mg to about 203 mg; phytin is presentin an amount selected from: 100 mg to about 475 mg, 100 mg to about 400mg, about 100 mg to about 202 mg, about 201 mg to about 600 mg, about201 mg to about 475 mg, about 201 to about 400 mg, about 400 mg to about600 mg, about 400 to about 475 mg, and about 475 mg to about 600 mg;pyridoxine is present in an amount selected from: about 0.22 mg to about10.11 mg, about 0.22 mg to about 6.01 mg, about 0.22 mg to about 2.69mg, about 2.69 mg to about 15.1 mg, about 2.69 mg to about 10.11 mg,about 2.69 mg to about 6.01 mg, about 5.4 mg to about 15.1 mg, about 5.4mg to about 10.1120 mg, and about 10.11 mg to about 15.1 mg; and musa ispresent in an amount selected from: about 1.46 mg to about 168 mg, about1.46 mg to about 85 mg, about 1.46 mg to about 42 mg, about 41 mg toabout 252 mg, about 41 mg to about 168 mg, about 41 mg to about 85 mg,about 85 mg to about 252 mg, about 85 mg to about 168 mg, and about 168mg to about 252 mg.

Most preferred is an oral dosage form or a plurality of dosage formscontaining magnesium citrate, phytin, pyridoxine, and musa wheremagnesium citrate is present in an amount of about 150 mg, phytin ispresent in an amount of about 200 mg, pyridoxine is present in an amountof about 5 mg, and musa is present in amount of about 250 mg.

Also disclosed is an oral dosage form or plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate, phytin,pyridoxine, and musa wherein the percent inhibition of the formation ofcalcium oxalate crystals caused by this combination of activeingredients is greater than about 92%, more preferably greater thanabout 96%, and most preferably greater than about 99%.

Also disclosed is an oral dosage form or plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate, phytin,and pyridoxine wherein the percent inhibition of the formation ofcalcium oxalate crystals caused by this combination of activeingredients is greater than about 89%, more preferably greater thanabout 94%, and most preferably greater than about 98%.

Also disclosed is an oral dosage form or plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate, phytin,and musa wherein the percent inhibition of the formation of calciumoxalate crystals caused by this combination of active ingredients isgreater than about 92%, more preferably greater than about 96%, and mostpreferably greater than about 100%.

Also disclosed is an oral dosage form or plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate,pyridoxine, and musa wherein the percent inhibition of the formation ofcalcium oxalate crystals caused by this combination of activeingredients is greater than about 59%, more preferably greater thanabout 62%, and most preferably greater than about 66%.

Also disclosed is an oral dosage form or plurality of dosage formscomprising as active ingredients citric acid, phytin, pyridoxine, andmusa wherein the percent inhibition of the formation of calcium oxalatecrystals caused by this combination of active ingredients is greaterthan about 88%, more preferably greater than about 100%, and mostpreferably greater than about 108%.

Also disclosed is an oral dosage form or plurality of dosage formscomprising as active ingredients magnesium citrate, phytin, pyridoxine,and musa wherein the percent inhibition of the formation of calciumoxalate crystals caused by this combination of active ingredients isgreater than about 99%, more preferably greater than about 104%, andmost preferably greater than about 106%.

Also disclosed herein are methods for treating and/or inhibitingformation of kidney stones.

In an embodiment, the method comprises administering an oral dosage formor a plurality of dosage forms disclosed herein to a patient in needthereof. The dosage form(s) can be administered to the patient one timeor multiple times per day, preferably one to four times per day and morepreferably twice per day. Multiple oral dosage forms can be taken perdosing, preferably one to four dosage forms, preferably one to twodosage forms, and more preferably 1 dosage form.

In an embodiment, the method comprises administering to a patient inneed thereof about 101 mg to about 700 mg citric acid; about 76 mg toabout 226 mg magnesium citrate; about 3 mg to about 600 mg phytin; about0.1 mg to about 15 mg pyridoxine; and about 1 mg to about 251 mg musa.In an embodiment, the method comprises administering to the patientabout 350 mg citric acid, about 150 magnesium citrate, about 200 mgphytin, about 5 mg pyridoxine, and about 250 mg musa. The administeringcan occur one time or multiple times per day, preferably 1 to 4 timesper day, and more preferably twice per day. The combination of thecitric acid, magnesium citrate, phytin, pyridoxine, and musa can beadministered to the patient in form of an oral dosage form, e.g. atablet or a capsule, preferably a capsule.

In an embodiment, the method comprises administering to a patient inneed thereof any of the preferred amounts of active ingredientsdisclosed in the various embodiments herein.

In an embodiment, the method comprises administering to a patient inneed thereof about 101 mg to about 699 mg citric acid, about 77 mg toabout 227 mg magnesium citrate, about 3.06 mg to about 600 mg phytin,and about 0.23 mg to about 15.13 pyridoxine. In an embodiment, themethod comprises administering to the patient about 350 mg citric acid,about 150 magnesium citrate, about 200 mg phytin, and about 5 mgpyridoxine. The combination of the citric acid, magnesium citrate,phytin, and pyridoxine, can be administered to the patient in form of anoral dosage form, e.g. a tablet or a capsule, preferably a capsule.

In an embodiment, the method comprises administering to a patient inneed thereof about 102 mg to about 1052 mg citric acid, about 2.32 mg toabout 201 mg magnesium citrate, about 100 mg to about 600 mg phytin, andabout 1.51 mg to about 251 mg musa. In an embodiment, the methodcomprises administering to the patient about 350 mg citric acid, about150 magnesium citrate, about 200 mg phytin, and about 250 mg musa. Thecombination of the citric acid, magnesium citrate, phytin, and musa canbe administered to the patient in form of an oral dosage form, e.g. atablet or a capsule, preferably a capsule.

In an embodiment, the method comprises administering to a patient inneed thereof about 101 mg to about 1051 mg citric acid; about 2.14 mg toabout 226 mg magnesium citrate; about 0.25 mg to about 10.23 mgpyridoxine; and about 41.02 mg to about 252 mg musa. In an embodiment,the method comprises administering to the patient about 350 mg citricacid, about 150 magnesium citrate, about 5 mg pyridoxine, and about 250mg musa. The combination of the citric acid, magnesium citrate,pyridoxine, and musa can be administered to the patient in form of anoral dosage form, e.g. a tablet or a capsule, preferably a capsule.

In an embodiment, the method comprises administering to a patient inneed thereof about 101 mg to less than about 700 mg citric acid; about101 mg to about 600 mg phytin; about 0.23 mg to about 15.12 mgpyridoxine; and about 1.46 mg to about 252 mg musa. In an embodiment,the method comprises administering to the patient about 350 mg citricacid, about 200 mg phytin, about 5 mg pyridoxine, and about 250 mg musa.The combination of the citric acid, phytin, pyridoxine, and musa can beadministered to the patient in form of an oral dosage form, e.g. atablet or a capsule, preferably a capsule.

In an embodiment, the method comprises administering to the patientabout 150 mg magnesium citrate, about 200 mg phytin, about 5 mgpyridoxine, and about 250 mg musa. The combination of the magnesiumcitrate, phytin, pyridoxine, and musa can be administered to the patientin form of an oral dosage form, e.g. a tablet or a capsule, preferably acapsule. In an embodiment, the method comprises administering to apatient in need thereof about 2.03 mg to about 203 mg magnesium citrate;about 100 mg to about 600 mg phytin; about 0.22 mg to about 15.1 mgpyridoxine; and about 1.46 mg to about 252 mg musa.

In any of the embodiments of the method for treating and/or inhibitingformation of kidney stones disclosed herein, the administering can occurone time or multiple times per day, preferably 1 to 4 times per day, andmore preferably twice per day.

Also disclosed is a method of inhibiting growth of calcium oxalatecrystals.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with an oral dosage form or a plurality ofdosage forms disclosed herein.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with a composition comprising as activeingredients citric acid, magnesium citrate, phytin, pyridoxine, andmusa. A preferred range for citric acid is about 101 mg to about 700 mg;and more preferably about 101 mg to about 352 mg, about 101 mg to about176 mg, about 176 mg to about 700 mg, or about 352 mg to about 700 mg. Apreferred range for magnesium citrate is about 76 mg to about 226 mg;and more preferably about 76 mg to about 201 mg, about 76 mg to about150 mg, about 150 to about 226 mg, or about 201 mg to about 226 mg. Apreferred range for phytin is about 3 mg to about 600 mg; morepreferably about 3 mg to about 400 mg, about 3 mg to about 202 mg, about3 mg to about 100 mg, about 100 mg to about 600 mg, about 201 mg toabout 600 mg, or about 400 mg to about 600 mg. A preferred range forpyridoxine is about 0.2 mg to about 15 mg; more preferably about 0.2 mgto about 10.1 mg, about 0.2 mg to about 6 mg, about 0.2 mg to about 2.7mg, about 2.7 mg to about 15 mg, about 6.0 mg to about 15 mg, or about10 mg to about 15 mg. A preferred range for musa is about 1 mg to about251 mg; more preferably about 1 mg to about 167 mg, about 1 mg to about85 mg, about 1 mg to about 41 mg, about 41 mg to about 251 mg, about 85mg to about 251 mg, or about 167 mg to about 251 mg. In an embodiment,the composition comprises about 101 mg to about 700 mg citric acid;about 76 mg to about 226 mg magnesium citrate; about 3 mg to about 600mg phytin; about 0.1 mg to about 15 mg pyridoxine; and about 1 mg toabout 251 mg musa; specifically, the composition comprises citric acidin an amount of about 350 mg, magnesium citrate in an amount of about150 mg, phytin in an amount of about 200 mg, pyridoxine in an amount ofabout 5 mg, and musa in amount of about 250 mg.

In an embodiment, the method comprises contacting an aqueous solutioncomprising calcium oxalate with a composition comprising as activeingredients any four of citric acid, magnesium citrate, phytin,pyridoxine, and musa. In an embodiment, the amount of each activeingredient is any of the amounts for that active ingredient disclosedherein. In an embodiment, the method comprises contacting an aqueoussolution comprising calcium oxalate with any of the preferred amounts ofactive ingredients disclosed in the various embodiments herein.

Definitions

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of ordinary skillin the art to which this invention belongs. In the event that there is aplurality of definitions for a term used herein, those definitions inthis section shall prevail.

The terms “a” and “an” do not denote a limitation of quantity, butrather denote the presence of at least one of the referenced item.

The term “about” as used herein is inclusive of the stated value andmeans within the routine experimental error associated with measurementof the particular quantity (i.e., the limitations of the measurementsystem) or in the case of a weight, within ±10% of the stated value.

The term “active agent” or “active ingredient” as used herein includesall pharmaceutically acceptable molecules, plant extracts, vitamins,salt forms, crystalline forms, amorphous form, polymorphic forms,solvates, and hydrates that are useful for treating a medical condition.

“Administering an oral dosage form or plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate, phytin,pyridoxine, and musa” or “co-administering a plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate, phytin,pyridoxine, and musa” means that each active ingredient is administeredsimultaneously in a single dosage form, administered concomitantly inseparate dosage forms, or administered in separate dosage formsseparated by some amount of time that is within the time in which all ofthe active ingredients are within the blood stream of a patient.

The terms “comprising”, “having”, “including”, and “containing” are tobe construed as open-ended terms (i.e., meaning “including, but notlimited to”).

A “dosage form” means a unit of administration of an active agent. An“oral dosage form” means a unit dosage form for oral administration.

As used herein “food” means a solid food with sufficient bulk and fatcontent that it is not rapidly dissolved and absorbed in the stomach.More specifically, the food is a meal, such as breakfast, lunch, ordinner. An oral dosage form administered to a patient “with food” isadministered to the patient between about 30 minutes prior to eating ameal to about 2 hours after eating a meal; more specifically, the dosageis administered within 15 minutes of eating a meal. The term “withoutfood” is defined to mean the condition of the patient not havingconsumed solid food for about one hour prior to administration of theoral dosage form until about 2 hours after administration of the oraldosage form.

The term “kidney stone” includes a stone, crystal, calculus, ornephrolith that is formed and affects any part of the urinary tractincluding the kidney, bladder, and ureter.

The term “medical condition” includes disease, illness, ailment,syndrome, and/or disorder.

The term “patient” means a human or non-human animal in need of medicaltreatment.

The terms “treating” and “treatment” mean implementation of therapy withthe intention of reducing in severity or frequency symptoms, eliminationof symptoms or underlying cause, prevention of the occurrence ofsymptoms or their underlying cause, and improvement or remediation ofdamage.

By an “effective amount” or a “therapeutically effective amount” of anactive agent is meant a sufficient amount of the active agent to producea therapeutic effect in the patient. The amount that is “effective” willvary from subject to subject, depending on the age and general conditionof the individual, the particular active agent, and the like. Thus, itis not always possible to specify an exact “effective amount.” However,an appropriate “effective” amount in any individual case may bedetermined by one of ordinary skill in the art using routineexperimentation.

The suffix “(s)” as used herein is intended to include both the singularand the plural of the term that it modifies, thereby including one ormore of that term (e.g., the dosage form(s) includes one or more dosageforms).

Ingredients

Citric acid is a GRAS food additive that is well absorbed and isexcreted into the renal tubule where it forms soluble complexes withcalcium, reducing the concentration of free calcium in the urine. Citricacid can be in the form of citric acid or a citrate salt such asmagnesium citrate, calcium citrate or other physiologically acceptablesalts. Low urinary citrate excretion is a risk factor for thedevelopment of kidney stones. Citrate inhibits stone formation bycomplexing with calcium in the urine, inhibiting spontaneous nucleation,and preventing growth and agglomeration of crystals. Citric acid hasbeen shown to inhibit the initial crystallization of calciumhydroxyapatite at Randall's plaques as well as the aggregation ofcalcium oxalate crystals and their attachment to urinary epithelium. Forcitric acid, this term is defined to include other compounds thatprovide the equivalent amount of citrate ion in solution as the amountavailable from citric acid used in the invention.

Ingestion of alkali salts (i.e. potassium and magnesium salts) reducesurine calcium excretion and increases the reabsorption of calcium in theproximal tubule reabsorption. Oral administration of potassium citrateis known to prevent the recurrence of kidney stones. Potassium citrateattaches to calcium in the urine, preventing the formation of mineralcrystals that can develop into kidney stones. Potassium citrate alsoprevents the urine from becoming too acidic. This helps prevent uricacid or cysteine kidney stones from forming. Magnesium inhibits calciumoxalate crystallization in human urine and model systems by forming asoluble chelate with oxalate in the urine allowing for excretion.Magnesium also inhibits absorption of dietary oxalate from the gutlumen. Magnesium has been shown to inhibit crystal formation thusreducing the risk for forming kidney stones. Various forms of alkalisalt can be used in the compositions of this invention. For magnesiumcitrate, this term is defined to include other magnesium compounds thatprovide the equivalent amount of free magnesium ion in solution as theamount of magnesium citrate used in the invention.

Phytin is a calcium-magnesium salt of phytic acid that occurs in plants.Phytic acid (known as inositol hexakisphosphate (IP6), inositolpolyphosphate, or phytate when in salt form) has a strong bindingaffinity for calcium. Phytin acts by preventing crystallization ofcalcium salts. For phytin, this term is defined to include othercompounds that provide the equivalent amount of phytate ion in solutionas the amount available from phytin used in the invention.

Pyridoxine (4,5-Bis(hydroxymethyl)-2-methylpyridin-3-ol, or vitamin B6)reduces oxalate levels. It is believed that pyridoxine enhances theactivity of an enzyme (alanine:glyoxylate aminotransferase) whichdiverts metabolites to other uses in the body rather than having themform oxalate. For pyridoxine, this term is defined to include vitamersof vitamin B6, including pyridoxine (PN), pyridoxine 5′-phosphate (PNP),pyridoxal (PL), pyridoxal 5′-phosphate (PLP also known as P-S-P vitaminsupplement), pyridoxamine (PM), pyridoxamine 5′-phosphate (PMP) and4-Pyridoxic acid (PA).

Musa (extracts from the banana plant or stem) been used in traditionalmedicine to prevent stone growth and to aid stone passage. From amechanistic standpoint, extracts from Musa normalize multiple abnormalurinary parameters which are known to induce stone growth, includingcalcium, phosphate, and oxalate. In this manner, high levels of theprecipitating species that initiate stone growth are no longer excretedinto the urine at high levels. Furthermore, Musa decreases theexpression of liver glycolate oxidase and lactate dehydrogenase, enzymesassociated with the production of oxalate in the body. In addition tothese activities, Musa extracts have significant diuretic effect thataids the passage of any stones as they are generated (Devi, V. K. etal., Ancient Science of Life, 1993, 12(3&4):451-461; Pillai, R. G.Ancient Science of Life, 1995, 15(1):2-6; Patankar, S. et al., 2008, TheJournal of Alternative and Complementary Medicine 14(10):1287-90;Prasobh, G. R., International Journal of Research in Pharmaceutical andBiomedical Sciences, 2012, 3(4):1251-1255). For musa, this term isdefined to include all musa varieties listed in World Checklist ofSelected Plant Families. Royal Botanic Gardens, Kew.

Formulation

Active agents used in this invention can be formulated into any oraldosage form including, solid, semi-solid, liquid, powder, sachet, andthe like. Solid oral dosage forms can include, for example, a tablet, acapsule (hard or soft), or subunits, and the like. “Subunit” includes aminitablet, a bead, a spheroid, a microsphere, a seed, a pellet, acaplet, a microcapsule, a granule, a particle, and the like that canprovide an oral dosage form alone or when combined with other subunits.Exemplary semi-solid or liquid dosage forms include a suspension, asolution, an emulsion, and the like.

The oral dosage form can be formulated for a specific type of releaseincluding immediate-release, controlled-release, sustained-release, orextended-release.

Exemplary solid oral dosage forms can be prepared by combining activeagents with one or more pharmaceutically acceptable excipients and thenforming into the dosage form. As used herein, “pharmaceuticallyacceptable excipient” means any other component added to thepharmaceutical formulation other than the active agent. Excipients maybe added to facilitate manufacture, enhance stability, enhance productcharacteristics, enhance bioavailability, enhance patient acceptability,etc. Pharmaceutical excipients include carriers, fillers, binders,disintegrants, lubricants, glidants, granulating agent, compressionaids, colors, sweeteners, preservatives, suspending agents, dispersingagents, film formers, flavors, printing inks, buffer agents, pHadjusters, preservatives etc. In some instances, a single material willmeet two or more of the foregoing general classifications.

Exemplary pharmaceutically acceptable excipients include fillers, suchas water-insoluble filler, water soluble filler, or a combinationthereof. The filler may be a water-insoluble filler, such as carnaubawax, stearic acid, silicon dioxide, titanium dioxide, talc, alumina,starch, kaolin, polacrilin potassium, powdered cellulose,microcrystalline cellulose, sodium citrate, dicalcium phosphate, or acombination thereof. Exemplary water-soluble fillers include watersoluble sugars and sugar alcohols, specifically lactose, glucose,fructose, sucrose, mannose, dextrose, galactose, the corresponding sugaralcohols and other sugar alcohols, such as mannitol, sorbitol, xylitol,or a combination thereof.

Exemplary binders include alginic acid, a carbomer,carboxymethylcellulose calcium, carboxymethylcellulose sodium,carrageenan, cellulose acetate phthalate, chitosan, ethyl cellulose,guar gum, hydroxyethyl cellulose, hydroxyethylmethyl cellulose,hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methylcellulose, microcrystalline cellulose, poloxamer, polyethylene oxide,polymethacrylates, povidone, a saccharide, starch, partiallypregelatinized starch, and the like, or a combination thereof.

Exemplary disintegrants include alginic acid, carboxymethylcellulosecalcium, carboxymethylcellulose sodium, cross-linked sodiumcarboxymethylcellulose (sodium croscarmellose), powdered cellulose,chitosan, croscarmellose sodium, crospovidone, guar gum, low substitutedhydroxypropyl cellulose, methyl cellulose, microcrystalline cellulose,sodium alginate, sodium starch glycolate, partially pregelatinizedstarch, pregelatinized starch, starch, sodium carboxymethyl starch, andthe like, or a combination thereof.

Exemplary lubricants include calcium stearate, magnesium stearate,glyceryl behenate, glyceryl palmitostearate, hydrogenated castor oil,light mineral oil, sodium lauryl sulfate, magnesium lauryl sulfate,sodium stearyl fumarate, stearic acid, zinc stearate, or a combinationthereof.

Exemplary glidants include colloidal silica, amorphous silica,precipitated silica, talc, calcium phosphate tribasic, calcium silicate,magnesium silicate, magnesium trisilicate, or a combination thereof, andthe like.

Active agents can be formulated into dosage forms using known techniquesin the pharmaceutical art including dry blending and compression, wetgranulation, encapsulation, dry granulation or wet granulation followedby compression or compaction, melt extrusion and spheronization,layering (e.g., spray layering suspension or solution), and the like.Examples of such techniques include direct compression, usingappropriate punches and dies, the punches and dies are fitted to asuitable rotary tableting press; injection or compression molding usingsuitable molds fitted to a compression unit, granulation followed bycompression; and extrusion in the form of a paste, into a mold or to anextrudate to be cut into lengths.

Tablets can be prepared by compression into a compressed form usingconventional tableting equipment using standard techniques. Techniquesand compositions for making tablets (compressed and molded) aredescribed in Remington's Pharmaceutical Sciences, (Aurther Osol.,editor), pp. 1553-1593 (1980).

Layering techniques suitable to prepare subunits include coating inertcores with a layering solution or dispersion of the active agent and apharmaceutically acceptable excipient. Repeated layering can be used tobuild the subunit size and increase active agent amount.

The controlled-release dosage form can be prepared usingcontrolled-release matrix materials, controlled-release coatingmaterials, or a combination thereof.

The dosage forms may include functional or nonfunctional coatings. By“functional coating” is meant to include a coating that modifies therelease properties of the total composition, for example, acontrolled-release coating including a sustained-release ordelayed-release coating. By “non-functional coating” is meant to includea coating that is not a functional coating, for example, a cosmeticcoating. A non-functional coating can have some impact on the release ofthe active agent due to the initial dissolution, hydration, perforationof the coating, etc., but would not be considered to be a significantdeviation from the non-coated composition.

Exemplary non-functional coatings include film forming polymers such asa water soluble hydroxyl cellulose (e.g. hydroxylpropyl methylcellulose,etc.), polyvinyl alcohol, and the like; optionally further including anadditional pharmaceutically acceptable coating excipient such as aplasticizer, a stabilizer, an anti-tacking agent (e.g., talc), asurfactant, and the like, or a combination thereof.

Exemplary functional coatings include polymers such as cellulose esters(e.g. ethylcellulose); a polymethacrylate (e.g. copolymers of acrylicand methacrylic acid esters), and the like; optionally further includingan additional pharmaceutically acceptable coating excipient such as aplasticizer, a stabilizer, a water-soluble component (e.g. poreformers), an anti-tacking agent (e.g., talc), a surfactant, and thelike, or a combination thereof.

Suitable methods known in the pharmaceutical art can be used to applythe coating material. Processes such as simple or complex coacervation,interfacial polymerization, liquid drying, thermal and ionic gelation,spray drying, spray chilling, fluidized bed coating, pan coating, orelectrostatic deposition may be used.

Dosing and administration

Oral dosage forms containing active agents can be administered toprevent or treat formation of kidney stones anywhere from once tomultiple times per day, preferably one to four times per day and mostpreferably twice per day. Multiple dosage forms can be taken per dosing,preferably one to four dosage forms and most preferably one to twodosage forms and ideally, 1 dosage form. The dosage form can be takenwith or without regard to food.

EXAMPLES Example 1

A series of tests was run to evaluate the impact that variousformulations of ingredients had on the rate of calcium oxalate crystalgrowth. Formulations were evaluated for their ability to achieve 100%inhibition of the in vitro growth rate of calcium oxalate crystals.Initially, the growth of calcium oxalate crystals in aqueous solutionwas determined by UV-Visible spectroscopy and is referred to as a“Control Vehicle”. Then, various formulations were evaluated for theirability to inhibit the growth rate of calcium oxalate crystals comparedto the Control Vehicle.

All reagents were chemical grade or plant extracts as listed in theReagent

Table below. Other grades and sources of reagents may be used.

Reagent Table Reagent Chemical Grade Commercial Source Lot # Calcium ACSanalytical Mallinkrodt G23H14 chloride, grade dihydrate Sodium ACSSigma-Aldrich MKBP6508V oxalate Reagent ≧99.5% Sodium AR analyticalFisher Scientific 7372KVND acetate reagent Sodium USP food gradeMallinkrodt 7532KVPG Chloride Banana stem Acetar Biotech TY140603extract - Musa Phytin TCI America FFEKL-FA Magnesium BulkSupplements.com20141019 citrate Pyridoxine ≧98% HPLC Sigma Aldrich SLBK1634V HCl Citricacid TCI America SVJKMIT

Experimental Spectrophotometric Method:

The spectrophotometric method employed was based on the work of Chow(Chow, 2004b, Citrate inhibits growth of residual fragments in an invitro model of calcium oxalate renal stones. Kidney International,665:1724-1730) and is briefly described below. The study was conductedusing a sodium acetate/sodium chloride buffer at pH 5.7 as recommendedby Khan (Khan 2012, Antiurolithic activity of Origanum vulgare ismediated through multiple pathways BMC Complementary and AlternativeMedicine 11: 96-112.).

The kinetics of calcium oxalate crystal formation in a control vehiclewere characterized by the slope method of Hess (Hess, B. et al.,Nephrol. Dial. Transplant, 2000, 15(3): 366-374). Briefly, 1.6milliliters of an 8.5 mM solution of calcium chloride was added to aplastic cuvette and 1.6 milliliters of a 1.5 mM sodium oxalate solutionwas then added. Both of the solutions were prepared in a buffer composedof 50 mM sodium acetate and 100 mM sodium chloride at pH 5.7.Immediately upon combining the solutions, the cuvette was mixed byinversion and the kinetics of calcium oxalate crystal formation weremonitored at 620 nm using a spectrophotometer. A Vernier SpectroVisspectrophotometer was used. Measurements were made in the Absorbanceversus Time mode, using ten (10) minutes for a full run with anacquisition of 10 samples per minute. Other spectrophotometers,wavelengths, and methods may also be used to determine calcium oxalatecrystal formation over time.

The inhibition of the kinetics of calcium oxalate crystal formation bythe various Test Solutions set forth below was determined using themethod described above with the following change. Before the sodiumoxalate solution was added, 200 μL of the Test Solution is added to thecuvette. The remainder of the procedure was the same as described above.The inhibition of crystal growth was determined by comparison of theeffect of the Test Solution on the slope of the initial velocity(compared to vehicle control, during the first two minutes), asdescribed by Hess (Hess, 2000). Individual replicates identified asoutliers by the Grubb's test were not included in the calculation(Grubbs, Frank E., 1950, Sample criteria for testing outlyingobservations, The Annals of Mathematical Statistics 21(1), p. 27-58.).Other methods of determining percent inhibition of calcium oxalatecrystal formation, such as by individual runs or other statisticalmethods are also possible.

The Test Solutions were prepared by adding the following ingredients inthe amounts given in Tables 1 and 11-15 in the order listed (for aningredient not used in Matrix 1 through 5, the order remained the samebut that ingredient was omitted) to a 100 mL volumetric flask:

-   -   Citric acid—added as a dry powder to a 100 mL volumetric flask;    -   Magnesium citrate—added as a dry powder to above volumetric        flask and 50 mL distilled H₂O added and vortexed until clear    -   Phytin—added to above volumetric flask and vortexed until clear    -   Pyridoxine—added to above volumetric flask and vortexed until        clear    -   Musa—50 mL of the prepared solution (see below) added to the        above volumetric flask and made up to final volume of 100 mL        with water.

The Musa samples were prepared by placing the indicated amount of Musa,as a dry powder, (see Table 1) in a 100 mL volumetric flask and makingup to volume with water. The flask was vortexed intermittently for 5minutes. At this time the sample was transferred to a centrifuge tubeand centrifuged at 3000 rpm for 30 minutes. 50 mL of the supernatant wascarefully transferred to a 50 mL volumetric flask and vortexed to assurecomplete solubility. This 50 mL homogeneous solution was transferred tothe original 100 mL volumetric flask and vortexed to assure completesolubility.

For Matrix 5 test solutions, which did not include any citric acid, theentire procedure was the same except magnesium citrate was added as adry powder to a 100 mL volumetric flask to which 40 mL distilled H₂O wasadded and then sufficient 1 N HCl to impart a pH of between 1 and 2 tothe final solution. The flask was vortexed until complete dissolution.The total volume of the magnesium citrate solution was <50 mL. Phytin,pyridoxine, and musa were added to complete the 100 mL Matrix 5 testsolutions as described above. For Matrix 5 Test solution 7, magnesiumcitrate (203 mg) was added to a 100 mL volumetric flask to which 35 mLdistilled water added and then 2.5 mL 1 N HCl was added, yielding a pHof between 1 and 2. The flask was vortexed until clear. To thisvolumetric flask was added 600 mg phytin and then 10 mL distilled water.The solution was vortexed, and then permitted to stand for approximately3 minutes until the top of the liquid was clear. The pH was pH 6. Anadditional 2.5 mL 1 N HCl was added to yield a pH between 1 and 2. Theflask was vortexed until clear. Pyridoxine and musa were then added tocomplete the 100 mL Matrix 5 Test Solution, as described above.

TABLE 1 Amounts of Active Ingredients in Five Ingredient Test Solutions.Active Test Test Test Test Test Test Test Ingredient Solution 1 Solution2 Solution 3 Solution 4 Solution 5 Solution 6 Solution 7 Citric Acid 352 mg  101 mg  1050 mg 700 mg  352 mg  176 mg  351 mg Mg Citrate  151mg   76 mg  2.02 mg 226 mg  201 mg  150 mg  152 mg Phytin  202 mg  201mg   100 mg 3.03  600 mg  400 mg  200 mg Pyridoxine  5.4 mg 10.1 mg 5.99 mg 2.67  0.2 mg 15.1 mg  5.3 mg Musa  251 mg  251 mg   167 mg  85mg   41 mg  1.4 mg  251 mg

FIG. 1 shows the absorbance as function of time for the first 10 minutesand measures the formation of calcium oxalate over time for the ControlVehicle runs used for Test Solution 1. From the figure it can be seenthat calcium oxalate crystals are indeed forming during the ten minutesof the run. FIG. 2 shows the slopes of the curves for the initial twominutes of the runs for the Control Vehicle used for Test Solution 1.Since the data was linear (R²>0.95) for the first two (2) minutes, thisdata was plotted for slope determination by linear regression analysis.FIG. 3 shows the absorbance as function of time for the first 10 minutesand measures the formation of calcium oxalate over time for the ControlVehicle runs used for Test Solution 1. FIG. 4 shows the slopes of thecurves for the initial two minutes of the runs for Test Solution 1.Since the data was linear (R²>0.95) for the first two (2) minutes, thisdata was plotted for slope determination by linear regression analysis.

Table 2 shows the analysis of the slopes FIGS. 2 and 4. Each run isdesignated as a Replicate. Outlier data identified using the Grubbs'Test (Grubbs, 1950) were not included in % inhibition calculations. Themedian % Inhibition was calculated according to the method of Hess(Hess, 2000) using the following equation:

% Inhibition=100%*(1−(Slope of Test Solution/Slope of Control Vehicle)).

The mean (average) percent inhibition can also be calculated from thedata. Median and mean percent inhibitions are presented in Tables 9,11-15. In some embodiments, the median percent inhibition is thepreferred measure of percent inhibition.

TABLE 2 Data Analysis for Slope Test, Control Vehicle & Test Solution 1Replicate Replicate Replicate Replicate Replicate Replicate Median % #1#2 #3 #4 #5 #6 Median Inhibition Control Vehicle 0.0047 0.0172 0.00220.0042 0.0057 0.0036 0.00445 Test Solution 1 −0.0002 0.0002 0.000030.00007 −0.0003 0.001 0.00005 98.8764

FIG. 5 shows the absorbance as function of time for the first 10 minutesand measures the formation of calcium oxalate over time for the ControlVehicle runs used for Test Solution 2. From the figure it can be seenthat calcium oxalate crystals are indeed forming during the ten minutesof the run. FIG. 6 shows the slopes of the curves for the initial twominutes of the runs for the Control Vehicle used for Test Solution 2.Since the data was linear (R²>0.95) for the first two (2) minutes, thisdata was plotted for slope determination by linear regression analysis.FIG. 7 shows the absorbance as function of time for the first 10 minutesand measures the formation of calcium oxalate over time for the ControlVehicle runs used for Test Solution 1. FIG. 8 shows the slopes of thecurves for the initial two minutes of the runs for Test Solution 2.Since the data was linear (R²>0.95) for the first two (2) minutes, thisdata was plotted for slope determination by linear regression analysis.Table 3 shows the analysis of the slopes FIGS. 6 and 8. Each run isdesignated as a Replicate.

TABLE 3 Data Analysis for Slope Test, Control Vehicle & Test Solution 2Replicate Replicate Replicate Replicate Replicate Replicate Median % #1#2 #3 #4 #5 #6 Median Inhibition Control Vehicle −0.028 0.0666 0.06340.0855 0.0406 0.0334 0.0634 Test Solution 2 −0.0007 −0.0008 −0.0012−0.0012 — — −0.001 101.5773

FIG. 9 shows the absorbance as function of time for the first 10 minutesand measures the formation of calcium oxalate over time for the ControlVehicle runs used for Test Solution 3. From the figure it can be seenthat calcium oxalate crystals are indeed forming during the ten minutesof the run. FIG. 10 shows the slopes of the curves for the initial twominutes of the runs for the Control Vehicle used for Test Solution 3.Since the data was linear (R²>0.95) for the first two (2) minutes, thisdata was plotted for slope determination by linear regression analysis.FIG. 11 shows the absorbance as function of time for the first 10minutes and measures the formation of calcium oxalate over time for theControl Vehicle runs used for Test Solution 3. FIG. 12 shows the slopesof the curves for the initial two minutes of the runs for Test Solution3. Since the data was linear (R²>0.95) for the first two (2) minutes,this data was plotted for slope determination by linear regressionanalysis. Table 4 shows the analysis of the slopes FIGS. 10 and 12. Eachrun is designated as a Replicate.

TABLE 4 Data Analysis for Slope Test, Control Vehicle & Test Solution 3Replicate Replicate Replicate Replicate Median % #1 #2 #3 #4 MedianInhibition Control Vehicle 0.0073 0.0123 0.0129 0.0115 0.0119 TestSolution 3 0.0014 0.0077 0.0039 0.0035 0.0035 70.5882

FIG. 13 shows the absorbance as function of time for the first 10minutes and measures the formation of calcium oxalate over time for theControl Vehicle runs used for Test Solution 4. From the figure it can beseen that calcium oxalate crystals are indeed forming during the tenminutes of the run. FIG. 14 shows the slopes of the curves for theinitial two minutes of the runs for the Control Vehicle used for TestSolution 4. Since the data was linear (R²>0.95) for the first two (2)minutes, this data was plotted for slope determination by linearregression analysis. FIG. 15 shows the absorbance as function of timefor the first 10 minutes and measures the formation of calcium oxalateover time for the Control Vehicle runs used for Test Solution 4. FIG. 16shows the slopes of the curves for the initial two minutes of the runsfor Test Solution 4. Since the data was linear (R²>0.95) for the firsttwo (2) minutes, this data was plotted for slope determination by linearregression analysis. Table 5 shows the analysis of the slopes FIGS. 14and 16. Each run is designated as a Replicate.

TABLE 5 Data Analysis for Slope Test, Control Vehicle & Test Solution 4Repli- Repli- Repli- Median % cate #1 cate #2 cate #3 Median InhibitionControl 0.0772 0.107 0.081 0.081 Vehicle Test 0.0026 0.0007 0.00060.0004 99.5679 Solution 4

FIG. 17 shows the absorbance as function of time for the first 10minutes and measures the formation of calcium oxalate over time for theControl Vehicle runs used for Test Solution 5. From the figure it can beseen that calcium oxalate crystals are indeed forming during the tenminutes of the run. FIG. 18 shows the slopes of the curves for theinitial two minutes of the runs for the Control Vehicle used for TestSolution 5. Since the data was linear (R²>0.95) for the first two (2)minutes, this data was plotted for slope determination by linearregression analysis. FIG. 19 shows the absorbance as function of timefor the first 10 minutes and measures the formation of calcium oxalateover time for the Control Vehicle runs used for Test Solution 5. FIG. 20shows the slopes of the curves for the initial two minutes of the runsfor Test Solution 5. Since the data was linear (R²>0.95) for the firsttwo (2) minutes, this data was plotted for slope determination by linearregression analysis. Table 6 shows the analysis of the slopes FIGS. 18and 20. Each run is designated as a Replicate.

TABLE 6 Data Analysis for Slope Test, Control Vehicle & Test Solution 5Repli- Repli- Repli- Median % cate #1 cate #2 cate #3 Median InhibitionControl 0.0851 0.0508 0.0467 0.0588 Vehicle Test 0.0007 0.0003 0.00040.0004 99.3197 Solution 5

FIG. 21 shows the absorbance as function of time for the first 10minutes and measures the formation of calcium oxalate over time for theControl Vehicle runs used for Test Solution 6. From the figure it can beseen that calcium oxalate crystals are indeed forming during the tenminutes of the run. FIG. 22 shows the slopes of the curves for theinitial two minutes of the runs for the Control Vehicle used for TestSolution 6. Since the data was linear (R²>0.95) for the first two (2)minutes, this data was plotted for slope determination by linearregression analysis. FIG. 23 shows the absorbance as function of timefor the first 10 minutes and measures the formation of calcium oxalateover time for the Control Vehicle runs used for Test Solution 6. FIG. 24shows the slopes of the curves for the initial two minutes of the runsfor Test Solution 6. Since the data was linear (R²>0.95) for the firsttwo (2) minutes, this data was plotted for slope determination by linearregression analysis. Table 7 shows the analysis of the slopes FIGS. 22and 24. Each run is designated as a Replicate.

TABLE 7 Data Analysis for Slope Test, Control Vehicle & Test Solution 6Replicate Replicate Replicate Replicate Replicate Median % #1 #2 #3 #4#5 Median Inhibition Control Vehicle 0.0068 0.0717 0.038 0.0594 0.00370.0224 Test Solution 6 −0.0033 −0.0035 −0.0028 −0.0045 −0.0012 −0.0031113.6161

Table 8 shows the analysis of the slopes of solution 7, a duplicate oftest solution 1, which was calculated similarly to Test Solution 1. Eachrun is designated as a Replicate. The data from these experiments areshown FIGS. 25-28.

TABLE 8 Data Analysis for Slope Test, Control Vehicle & Test Solution 7Replicate Replicate Replicate Replicate Replicate Replicate % #1 #2 #3#4 #5 #6 Median Inhibition Vehicle 0.0084 0.0204 0.0282 0.0054 0.01930.0306 0.01985 Test Solution 1 −0.0000005 −0.0003 −0.0002 0.0005 −0.0003−0.0002 −0.0002 101.0076

Table 9 shows the percent inhibition results (calculated as median andaverage) and the ingredient weights for Test Solutions 1 through TestSolution 7.

TABLE 9 Median and Mean Inhibition of Calcium Oxalate Crystal Growth by5 ingredient Test Solutions Test Test Test Test Test Test Test Solution1 Solution 2 Solution 3 Solution 4 Solution 5 Solution 6 Solution 7Median % 98.88 101.58 70.59 99.57 99.32 113.62 101.00 Inhibition Average% 96.26 103.11 64.39 99.48 99.27 92.44 99.19 Inhibition Citric Acid  352mg  101 mg  1050 mg  700 mg  352 mg  176 mg  351 mg Mg Citrate  151 mg  75 mg  2.02 mg  226 mg  201 mg  150 mg  152 mg Phytin  202 mg  201 mg  100 mg 3.03 mg  600 mg  400 mg  200 mg Pyridoxine  5.4 mg 10.2 mg 5.99 mg 2.67 mg  0.2 mg 15.1 mg  5.3 mg Musa  251 mg  251 mg   167 mg  85 mg   41 mg  1.4 mg  251 mg

The results in Table 9 show that compositions having about 101 mg toabout 700 mg citric acid; about 76 mg to about 226 mg magnesium citrate;about 3 mg to about 600 mg phytin; about 0.1 mg to about 15 mgpyridoxine; and about 1 mg to about 251 mg musa. result in a meanpercent inhibition of calcium oxalate crystal growth of at least about92%, while compositions having citric acid, magnesium citrate, phytin,pyridoxine, and musa concentrations outside these ranges areunexpectedly much less effective, resulting in mean percent inhibitionof calcium oxalate crystal growth of only about 64%.

Inhibition of the kinetics of calcium oxalate crystal formation was alsodetermined, using the method described above, for the four combinationsof four out of the five ingredients in Table 1 each including citricacid. Herein, each of these four-ingredient combinations is referred toas a “Matrix”. “Matrix 1” refers to a combination of citric acid,magnesium citrate, phytin, and pyridoxine. “Matrix 2” refers to acombination of citric acid, magnesium citrate, phytin, and musa. “Matrix3” refers to a combination of citric acid, magnesium citrate,pyridoxine, and musa. “Matrix 4” refers to a combination of citric acid,phytin, pyridoxine, and musa. Matrix 5 refers to a combination ofmagnesium citrate, phytin, pyridoxine, and musa. The amounts of theingredients in the Test Solutions for each of the five Matrices are setforth below in Tables 11-15, respectively, along with median and meanpercent inhibition values determined for each Test Solution.

FIGS. 30 to 53 are graphs showing absorbance as function of time andslope determinations for the Control Vehicle and Test Solutionreplicates for the six Matrix 1 Test Solutions.

FIGS. 54 to 77 are graphs showing absorbance as a function of time andslope determinations for the Control Vehicle and Test Solutionreplicates for the six Matrix 2 Test Solutions.

FIGS. 78 to 101 are graphs showing absorbance as a function of time andslope determinations for the Control Vehicle and Test Solutionreplicates for the six Matrix 3 Test Solutions.

FIGS. 102 to 125 are graphs showing absorbance as a function of time andslope determinations for the Control Vehicle and Test Solutionreplicates for the six Matrix 4 Test Solutions.

FIGS. 126 to 153 are graphs showing absorbance as a function of time andslope determinations for the Control Vehicle and Test Solutionsreplicates for the seven Matrix 5 Test Solutions.

Since the data was linear (R²>0.95) for the first two (2) minutes of theruns, that data was plotted for slope determination by linear regressionanalysis. The slopes determined for the Control Vehicle and TestSolutions 1-6 runs for each of Matrix 1, 2, 3, 4 and 5 are tabulated inTable 10. Table 10 further shows the results of analysis of the slopesto provide the median percent inhibition by each Test Solution. Each runis designated as a Replicate.

TABLE 10 Data Analysis for Slope Test for Control Vehicles and TestSolutions for Matrix 1, Matrix 2, Matrix 3, Matrix 4 and Matrix 5 Matrix1 through 5 - Four Ingredient Data Analysis for Slope Tests, ControlVehicles & Test Solutions % Inhibition Replicate 1 Replicate 2 Replicate3 Median Median Matrix 1 - Citric Acid, Mg Citrate, Phytin, PyridoxineMatrix 1 Control Vehicle 0.0081 0.0088 0.0145 0.0088 Test Solution 10.0004 −0.0004 −0.0006 −0.0004 104.5% Control Vehicle 0.0098 0.01990.0767 0.0199 Test Solution 2 −0.0013 −0.001 −0.0017 −0.0013 106.5%Control Vehicle 0.0119 0.0093 0.0171 0.0119 Test Solution 3 0.00140.0014 0.0004 0.0014 88.2% Control Vehicle 0.0469 0.0899 0.1103 0.0899Test Solution 4 0.0031 0.0009 0.001 0.001 98.9% Control Vehicle 0.01030.008 0.0482 0.0103 Test Solution 5 0.0006 0.0019 0.0001 0.0006 94.2%Control Vehicle 0.1182 0.1233 0.1278 0.1233 Test Solution 6 −0.0027−0.0022 −0.0027 −0.0027 102.2% Matrix 2 - Citric Acid, Mg Citrate,Phytin, Musa Matrix 2 Control Vehicle 0.0056 0.0071 0.0105 0.0105 TestSolution 1 −0.00009 −0.0006 0.0014 −0.00009 100.9% Control Vehicle0.0078 0.0037 0.0058 0.0068 Test Solution 2 −0.0026 −0.0011 −0.0013−0.0013 119.1% Control Vehicle 0.007 0.0141 0.0098 0.01195 Test Solution3 0.005 0.00006 0.0004 0.0004 96.7% Control Vehicle 0.0157 0.0059 0.01170.0157 Test Solution 4 0.0013 0.0011 0.0013 0.0013 91.7% Control Vehicle0.01 0.0359 0.0332 0.0332 Test Solution 5 0.0004 −0.0005 −0.0003 −0.0003100.9% Control Vehicle 0.0162 0.0349 0.013 0.0162 Test Solution 6−0.0019 −0.0029 −0.002 −0.002 112.3% Matrix 3 - Citric Acid, Mg Citrate,Pyridoxine, Musa Matrix 3 Control Vehicle 0.0072 0.0051 0.006 0.006 TestSolution 1 0.0005 0.0013 0.0012 0.00085 87.1% Control Vehicle 0.00640.0065 0.0131 0.0065 Test Solution 2 0.0036 0.0007 0.0008 0.0022 66.2%Control Vehicle 0.0109 0.008 0.0078 0.008 Test Solution 3 0.0013 0.00410.0026 0.0026 67.5% Control Vehicle 0.0093 0.0153 0.0184 0.0153 TestSolution 4 0.0076 0.0058 0.0026 0.0058 62.1% Control Vehicle 0.01680.0081 0.0135 0.0135 Test Solution 5 0.0023 0.0037 0.0045 0.0037 72.6%Control Vehicle 0.0224 0.0305 0.0186 0.0224 Test Solution 6 0.00570.0094 0.0225 0.0094 58.0% Matrix 4 - Citric Acid, Phytin, Pyridoxine,Musa Matrix 4 Control Vehicle 0.0073 0.017 0.0179 0.017 Test Solution 1−0.0018 −0.001 −0.0025 −0.0015 108.8% Control Vehicle 0.0246 0.03250.0124 0.0246 Test Solution 2 −0.003 −0.0023 −0.0024 −0.0024 109.8%Control Vehicle 0.0072 0.0052 0.0173 0.0072 Test Solution 3 −0.0021−0.00001 0.0002 −0.00001 100.1% Control Vehicle 0.0206 0.0228 0.01410.0206 Test Solution 4 0.0013 0.0025 0.0037 0.0025 87.9% Control Vehicle0.0052 0.0083 0.0067 0.0067 Test Solution 5 −0.0024 −0.002 −0.0025−0.0024 135.8% Control Vehicle 0.0089 0.0099 0.0071 0.0094 Test Solution6 −0.0039 −0.004 −0.0041 −0.004 142.6% Matrix 5 - Mg Citrate, Phytin,Pyridoxine and Musa Matrix 5 Control Vehicle 0.0306 0.0226 0.01050.01655 Test Solution 1 −0.0018 −0.0016 −0.001 −0.0016 109.7% ControlVehicle 0.0486 0.009 0.0082 0.0288 Test Solution 2 −0.0019 −0.0023−0.0016 −0.0019 106.6% Control Vehicle 0.0062 0.0115 0.0111 0.0111 TestSolution 3 −0.001 −0.0012 −0.001 −0.001 109.0% Control Vehicle 0.00910.0518 0.0139 0.0139 Test Solution 4 −0.0004 0.0018 0.0002 0.0002 98.6%Control Vehicle 0.0244 0.0089 0.0082 0.0089 Test Solution 5 −0.0028−0.0054 −0.0062 −0.0054 160.7% Control Vehicle 0.0185 0.0348 0.0120.0185 Test Solution 6 −0.0068 −0.0056 −0.0078 −0.0068 136.8% ControlVehicle 0.0217 0.0133 0.0214 0.0214 Test Solution 7 −0.0009 −0.00250.0003 −0.0009 104.2%

Table 11 shows the percent inhibition results (calculated as median andaverage) and the ingredient weights for Matrix 1 (citric acid, magnesiumcitrate, phytin, and pyridoxine) Test Solutions 1 through Test Solution6.

TABLE 11 Matrix 1 Test Solution Ingredient Amounts and Median and MeanPercent Inhibition of Calcium Oxalate Crystal Growth Test Test Test TestTest Test Matrix 1 Solution 1 Solution 2 Solution 3 Solution 4 Solution5 Solution 6 Ingredient mg mg mg mg mg mg Citric Acid 354 101 1051 699352 178 Mg Citrate 151 77 2.31 227 202 151 Phytin 201 201 100 3.06 600400 Pyridoxine 5.45 10.67 5.95 2.68 0.23 15.13 Median % inhibition104.55 106.53 88.24 98.89 94.17 102.19 Average % inhibition 101.25106.84 90.28 97.16 90.07 102.06

The results in Table 11 show that compositions where citric acid ispresent in an amount of about 101 mg to about 699 mg, magnesium citrateis present in an amount of about 77 mg to about 227 mg, phytin ispresent in an amount of about 3.06 mg to about 600 mg, and pyridoxine ispresent in an amount of about 0.23 mg to about 15.13 mg result in amedian percent inhibition of calcium oxalate crystal growth of at leastabout 94%, while compositions having citric acid, magnesium citrate,phytin, and pyridoxine concentrations outside these ranges areunexpectedly much less effective, resulting in median percent inhibitionof calcium oxalate crystal growth of only about 88%.

Table 12 shows the percent inhibition results (calculated as median andaverage) and the ingredient weights for Matrix 2 (citric acid, magnesiumcitrate, phytin, and musa) Test Solutions 1 through Test Solution 6.

TABLE 12 Matrix 2 Test Solution Ingredient Amounts and Median and MeanPercent Inhibition of Calcium Oxalate Crystal Growth Test Test Test TestTest Test Matrix 2 Solution 1 Solution 2 Solution 3 Solution 4 Solution5 Solution 6 Ingredient mg mg mg mg mg mg Citric Acid 352 102 1052 700351 177 Mg Citrate 151 77 2.32 226 201 150 Phytin 202 201 100 3.28 600401 Musa 251 251 167 86 41 1.51 Median % inhibition 100.86 119.12 96.6591.72 100.90 112.35 Average % inhibition 98.91 128.49 74.69 87.32 99.43111.81

The results in Table 12 show that compositions where citric acid ispresent in an amount of about 102 mg to about 1052 mg, magnesium citrateis present in an amount of about 2.32 mg to about 201 mg, phytin ispresent in an amount of about 100 mg to about 600 mg, and musa ispresent in an amount of about 1.51 mg to about 251 mg result in a medianpercent inhibition of calcium oxalate crystal growth of at least about96%, while compositions citric acid, magnesium citrate, phytin, and musaconcentrations outside these ranges are unexpectedly much lesseffective, resulting in median percent inhibition of calcium oxalatecrystal growth of only about 92%.

Table 13 shows the percent inhibition results (calculated as median andaverage) and the ingredient weights for Matrix 3 (citric acid, magnesiumcitrate, pyridoxine, and musa) Test Solutions 1 through Test Solution 6.

TABLE 13 Matrix 3 Test Solution Ingredient Amounts and Median and MeanPercent Inhibition of Calcium Oxalate Crystal Growth Test Test Test TestTest Test Matrix 3 Solution 1 Solution 2 Solution 3 Solution 4 Solution5 Solution 6 Ingredient mg mg mg mg mg mg Citric Acid 352 101 1051 700353 176 Mg Citrate 153 77 2.14 226 202 151 Pyridoxine 5.41 10.23 5.952.63 0.25 15.14 Musa 251 252 167 85 41.02 1.41 Median % inhibition 87.1266.15 67.50 62.09 72.59 58.04 Average % inhibition 82.52 75.62 67.8355.41 69.10 40.92

The results in Table 13 show that compositions where citric acid ispresent in an amount of about 101 mg to about 1051 mg, magnesium citrateis present in an amount of about 2.14 mg to about 226 mg, pyridoxine ispresent in an amount of about 0.25 mg to about 10.23 mg, and musa ispresent in an amount of about 41.02 mg to about 252 mg result in amedian percent inhibition of calcium oxalate crystal growth of at leastabout 62%, while compositions citric acid, magnesium citrate,pyridoxine, and musa concentrations outside these ranges areunexpectedly much less effective, resulting in median percent inhibitionof calcium oxalate crystal growth of only about 58%.

Table 14 shows the percent inhibition results (calculated as median andaverage) and the ingredient weights for Matrix 4 (citric acid, phytin,pyridoxine, and musa) Test Solutions 1 through Test Solution 6.

TABLE 14 Matrix 4 Test Solution Ingredient Amounts and Median and MeanPercent Inhibition of Calcium Oxalate Crystal Growth Test Test Test TestTest Test Matrix 4 Solution 1 Solution 2 Solution 3 Solution 4 Solution5 Solution 6 Ingredient mg mg mg mg mg mg Citric Acid 353 101 1050 700352 177 Phytin 203 202 101 3.01 600 400 Pyridoxine 5.45 10.20 6 2.690.23 15.12 Musa 252 252 167 86 41 1.46 Median % inhibition 108.82 109.76100.14 87.86 135.82 142.55 Average % inhibition 114.84 112.88 109.4085.49 135.85 147.32

The results in Table 14 show that compositions wherein citric acid ispresent in an amount of about 101 mg to less than about 700 mg, phytinis present in an amount of about 101 mg to about 600 mg, pyridoxine ispresent in an amount of about 0.23 mg to about 15.12 mg, and musa ispresent in an amount of about 1.46 mg to about 252 mg result in a medianpercent inhibition of calcium oxalate crystal growth of at least about100%, while compositions citric acid, phytin, pyridoxine, and musaconcentrations outside these ranges are unexpectedly much lesseffective, resulting in median percent inhibition of calcium oxalatecrystal growth of only about 88%.

Table 15 shows the percent inhibition results (calculated as median andaverage) and the ingredient weights for Matrix 5 (magnesium citrate,phytin, pyridoxine and musa) Test Solutions 1 through Test Solution 6.

TABLE 15 Matrix 5 Test Solution Ingredient Amounts and Median and MeanPercent Inhibition of Calcium Oxalate Crystal Growth Test Test Test TestTest Test Test Matrix 5 Solution 1 Solution 2 Solution 3 Solution 4Solution 5 Solution 6 Solution 7 Ingredient mg mg mg mg mg mg mgMagnesium Citrate 151 77 2.03 226 201 151 203 Phytin 202 201 100 3.02475 400 600 Pyridoxine 5.4 10.11 6.01 2.69 0.25 15.1 0.22 Musa 252 252168 85 42 1.46 41 Median % Inhibition 109.67 106.60 109.01 98.56 160.67136.76 104.21 Average % Inhibition 107.50 116.33 111.86 99.83 149.25139.28 107.18

The results in Table 15 show that compositions wherein magnesium citrateis present in an amount of about 2.03 mg to 203 mg, phytin is present inan amount of about 100 mg to about 600 mg, pyridoxine is present in anamount of about 0.22 mg to about 15.1 mg, and musa is present in anamount of about 1.46 mg to about 252 mg result in a median percentinhibition of calcium oxalate crystal growth of at least about 104%,while compositions magnesium citrate, phytin, pyridoxine, and musaconcentrations outside these ranges are unexpectedly much lesseffective, resulting in median percent inhibition of calcium oxalatecrystal growth of only about 98%.

Example 2 Oral Dosage Forms

TABLE 16 Five Ingredient Oral Capsule Ingredient Amount Citric Acidabout 101 mg to about 700 mg Mg Citrate about 76 mg to about 226 mgPhytin about 3 mg to about 600 mg Pyridoxine about 0.1 mg to about 15 mgMusa about 1 mg to about 251 mg

The five active ingredients are blended in the above amounts anddeposited into a hard shell capsule, e.g., a hydroxypropylmethylcellulose (HPMC) capsule, such as a DRcap™ (Capsugel®, Morristown,N.J.).

Tables 17-21 below provide additional oral capsule formulations. In eachformulation, the four active ingredients are blended in the indicatedamounts and deposited into a hard shell capsule, e.g., a hydroxypropylmethylcellulose (HPMC) capsule, such as a DRcap™ (Capsugel®, Morristown,N.J.).

TABLE 17 Matrix 1 Oral Capsule Ingredient Amount Citric Acid about 101mg to about 699 mg Mg Citrate about 77 mg to about 227 mg Phytin about3.06 mg to about 600 mg Pyridoxine about 0.23 mg to about 15.13 mg

TABLE 18 Matrix 2 Oral Capsule Ingredient Amount Citric Acid about 102mg to about 1052 mg Mg Citrate about 2.32 mg to about 201 mg Phytinabout 100 mg to about 600 mg Musa about 1.51 mg to about 251 mg

TABLE 19 Matrix 3 Oral Capsule Ingredient Amount Citric Acid about 101mg to about 1051 mg Mg Citrate about 2.14 mg to about 226 mg Pyridoxineabout 0.25 mg to about 10.23 mg Musa about 41.02 mg to about 252 mg

TABLE 20 Matrix 4 Oral Capsule Ingredient Amount Citric Acid about 101mg to less than about 700 Phytin about 101 mg to about 600 mg Pyridoxineabout 0.23 mg to about 15.12 mg Musa about 1.46 mg to about 252 mg

TABLE 21 Matrix 5 Oral Capsule Ingredient Amount Magnesium Citrate about2.03 mg to 203 mg Phytin about 100 mg to about 600 mg Pyridoxine about0.22 mg to about 15.1 mg Musa about 1.46 mg to about 252 mg

Set forth below are some embodiments of the oral dosage forms andmethods for disclosed herein.

Embodiment 1. An oral dosage form or a plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate, phytin,pyridoxine, and musa.

Embodiment 2. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein citric acid is present in an amount of about 101mg to about 700 mg.

Embodiment 3. The oral dosage form or plurality of dosage formsaccording to embodiment 2 wherein citric acid is present in an amountselected from: about 101 mg to about 352 mg, about 101 mg to about 176mg, about 176 mg to about 700 mg, and about 352 mg to about 700 mg.

Embodiment 4. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein magnesium citrate is present in an amount of about76 mg to about 226 mg.

Embodiment 5. The oral dosage form or plurality of dosage formsaccording to embodiment 4 wherein magnesium citrate is present in anamount selected from: about 76 mg to about 201 mg, about 76 mg to about150 mg, about 150 to about 226 mg, and about 201 mg to about 225 mg.

Embodiment 6. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein phytin is present in an amount of about 3 mg toabout 600 mg.

Embodiment 7. The oral dosage form or plurality of dosage formsaccording to embodiment 6 wherein phytin is present in an amountselected from: about 3 mg to about 400 mg, about 3 mg to about 202 mg,about 3 mg to about 100 mg, about 100 mg to about 600 mg, about 200 mgto about 600 mg, and about 400 mg to about 600 mg.

Embodiment 8. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein pyridoxine is present in an amount of about 0.2 mgto about 15 mg.

Embodiment 9. The oral dosage form or plurality of dosage formsaccording to embodiment 8 wherein pyridoxine is present in an amountselected from: about 0.2 mg to about 10 mg, about 0.2 mg to about 6 mg,about 0.2 mg to about 2.7 mg, about 2.7 mg to about 15 mg, about 6.0 mgto about 15 mg, and about 10 mg to about 15 mg.

Embodiment 10. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein musa is present in amount of about 1 mg to about251 mg.

Embodiment 11. The oral dosage form or plurality of dosage formsaccording to embodiment 10 wherein musa is present in an amount selectedfrom: about 1 mg to about 167 mg, about 1 mg to about 85 mg, about 1 mgto about 41 mg, about 41 mg to about 251 mg, about 85 mg to about 251mg, and about 167 mg to about 251 mg.

Embodiment 12. The oral dosage form or plurality of dosage forms ofembodiment 1 wherein citric acid is present in an amount of about 101 mgto about 700 mg; magnesium citrate is present in an amount of about 76mg to about 226 mg; phytin is present in an amount of about 3 mg toabout 600 mg; pyridoxine is present in an amount of about 0.1 mg toabout 15 mg; and musa is present in amount of about 1 mg to about 251mg.

Embodiment 13. The oral dosage form or plurality of dosage formsaccording to embodiment 12 wherein citric acid is present in an amountselected from: about 51 mg to about 352 mg, about 101 mg to about 176mg, about 176 mg to about 700 mg, and about 352 mg to about 700 mg;magnesium citrate is present in an amount selected from: about 76 mg toabout 201 mg, about 76 mg to about 150 mg, about 150 to about 226 mg,and about 201 mg to about 225 mg; phytin is present in an amountselected from: about 3 mg to about 400 mg, about 3 mg to about 202 mg,about 3 mg to about 100 mg, about 100 mg to about 600 mg, about 200 mgto about 600 mg, and about 400 mg to about 600 mg; pyridoxine is presentin an amount selected from: about 0.2 mg to about 10 mg, about 0.2 mg toabout 6 mg, about 0.2 mg to about 2.7 mg, about 2.7 mg to about 15 mg,about 6.0 mg to about 15 mg, and about 10 mg to about 15 mg; and musa ispresent in an amount selected from: about 1 mg to about 167 mg, about 1mg to about 85 mg, about 1 mg to about 41 mg, about 41 mg to about 251mg, about 85 mg to about 251 mg, and about 167 mg to about 251 mg.

Embodiment 14. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein the amount of one of the active ingredients isselected from: citric acid is present in an amount of about 101 mg toabout 700 mg; magnesium citrate is present in an amount of about 76 mgto about 226 mg; phytin is present in an amount of about 3 mg to about600 mg; pyridoxine is present in an amount of about 0.1 mg to about 15mg; and musa is present in amount of about 1 mg to about 251 mg.

Embodiment 15. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein the amounts of two of the active ingredients areselected from: citric acid is present in an amount of about 101 mg toabout 700 mg; magnesium citrate is present in an amount of about 76 mgto about 226 mg; phytin is present in an amount of about 3 mg to about600 mg; pyridoxine is present in an amount of about 0.1 mg to about 15mg; and musa is present in amount of about 1 mg to about 251 mg.

Embodiment 16. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein the amounts of 3 of the ingredients are selectedfrom: citric acid is present in an amount of about 101 mg to about 700mg; magnesium citrate is present in an amount of about 76 mg to about226 mg; phytin is present in an amount of about 3 mg to about 600 mg;pyridoxine is present in an amount of about 0.1 mg to about 15 mg; andmusa is present in amount of about 1 mg to about 251 mg.

Embodiment 17. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein the amounts of 4 of the ingredients are selectedfrom: citric acid is present in an amount of about 101 mg to about 700mg; magnesium citrate is present in an amount of about 76 mg to about226 mg; phytin is present in an amount of about 3 mg to about 600 mg;pyridoxine is present in an amount of about 0.1 mg to about 15 mg; andmusa is present in amount of about 1 mg to about 251 mg.

Embodiment 18. The oral dosage form or plurality of dosage forms ofembodiment 1, wherein citric acid is present in an amount of about 350mg; magnesium citrate is present in an amount of about 150 mg; phytin ispresent in an amount of about 200 mg; pyridoxine is present in an amountof about 5 mg; and musa is present in amount of about 250 mg.

Embodiment 19. The oral dosage form or a plurality of dosage formsaccording to any one of embodiments 1 to 18, wherein the percentinhibition of calcium oxalate crystal formation by the combination ofactive ingredients is greater than about 92%.

Embodiment 20. The oral dosage form or plurality of dosage formsaccording to embodiment 19, where the percent inhibition is greater thanabout 96%.

Embodiment 21. The oral dosage form or plurality of dosage formsaccording to embodiment 20 where the percent inhibition is greater thanabout 99%.

Embodiment 22. An oral dosage form or a plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate, phytin,and pyridoxine.

Embodiment 23. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein citric acid is present in an amount of about 101mg to about 699 mg.

Embodiment 24. The oral dosage form or plurality of dosage formsaccording to embodiment 23, wherein citric acid is present in an amountselected from: about 101 mg to about 354 mg, about 101 mg to about 178mg, about 178 mg to about 699 mg, about 178 mg to about 354 mg, andabout 352 mg to about 699 mg.

Embodiment 25. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein magnesium citrate is present in an amount ofabout 77 mg to about 227 mg.

Embodiment 26. The oral dosage form or plurality of dosage formsaccording to embodiment 25 wherein magnesium citrate is present in anamount selected from: about 77 mg to about 202 mg, about 77 mg to about151 mg, about 151 to about 227 mg, about 151 to about 202 mg, and about202 mg to about 227 mg.

Embodiment 27. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein phytin is present in an amount of about 3.06 mgto about 600 mg.

Embodiment 28. The oral dosage form or plurality of dosage formsaccording to embodiment 27 wherein phytin is present in an amountselected from: about 3.06 mg to about 400 mg, about 3.06 mg to about 201mg, about 3.06 mg to about 100 mg, about 100 mg to about 600 mg, about100 mg to about 400 mg, about 100 mg to about 201 mg, about 201 mg toabout 600 mg, about 201 mg to about 400 mg, and about 400 mg to about600 mg.

Embodiment 29. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein pyridoxine is present in an amount of about 0.23mg to about 15.13 mg.

Embodiment 30. The oral dosage form or plurality of dosage formsaccording to embodiment 29 wherein pyridoxine is present in an amountselected from: about 0.23 mg to about 10.67 mg, about 0.23 mg to about5.95 mg, about 0.23 mg to about 2.68 mg, about 2.68 mg to about 15.13mg, about 2.68 mg to about 10.67 mg, about 2.68 mg to about 5.95 mg,about 5.45 mg to about 15.13 mg, about 5.45 mg to about 10.67 mg, andabout 10.67 mg to about 15.13 mg.

Embodiment 31. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein citric acid is present in an amount of about 101mg to about 699 mg, magnesium citrate is present in an amount of about77 mg to about 227 mg, phytin is present in an amount of about 3.06 mgto about 600 mg, and pyridoxine is present in an amount of about 0.23 mgto about 15.13 mg.

Embodiment 32. The oral dosage form or plurality of dosage formsaccording to embodiment 31 wherein citric acid is present in an amountselected from: about 101 mg to about 354 mg, about 101 mg to about 178mg, about 178 mg to about 699 mg, about 178 mg to about 354 mg, andabout 352 mg to about 699 mg; magnesium citrate is present in an amountselected from: about 77 mg to about 202 mg, about 77 mg to about 151 mg,about 151 to about 227 mg, about 151 to about 202 mg, and about 202 mgto about 227 mg; phytin is present in an amount selected from: about3.06 mg to about 400 mg, about 3.06 mg to about 201 mg, about 3.06 mg toabout 100 mg, about 100 mg to about 600 mg, about 100 mg to about 400mg, about 100 mg to about 201 mg, about 201 mg to about 600 mg, about201 mg to about 400 mg, and about 400 mg to about 600 mg; and pyridoxineis present in an amount selected from: about 0.23 mg to about 10.67 mg,about 0.23 mg to about 5.95 mg, about 0.23 mg to about 2.68 mg, about2.68 mg to about 15.13 mg, about 2.68 mg to about 10.67 mg, about 2.68mg to about 5.95 mg, about 5.45 mg to about 15.13 mg, about 5.45 mg toabout 10.67 mg, and about 10.67 mg to about 15.13 mg.

Embodiment 33. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein the amount of one of the active ingredients isselected from: citric acid is present in an amount selected from: about101 mg to about 354 mg, about 101 mg to about 178 mg, about 178 mg toabout 699 mg, about 178 mg to about 354 mg, and about 352 mg to about699 mg; magnesium citrate is present in an amount selected from: about77 mg to about 202 mg, about 77 mg to about 151 mg, about 151 to about227 mg, about 151 to about 202 mg, and about 202 mg to about 227 mg;phytin is present in an amount selected from: about 3.06 mg to about 400mg, about 3.06 mg to about 201 mg, about 3.06 mg to about 100 mg, about100 mg to about 600 mg, about 100 mg to about 400 mg, about 100 mg toabout 201 mg, about 201 mg to about 600 mg, about 201 mg to about 400mg, and about 400 mg to about 600 mg; and pyridoxine is present in anamount selected from: about 0.23 mg to about 10.67 mg, about 0.23 mg toabout 5.95 mg, about 0.23 mg to about 2.68 mg, about 2.68 mg to about15.13 mg, about 2.68 mg to about 10.67 mg, about 2.68 mg to about 5.95mg, about 5.45 mg to about 15.13 mg, about 5.45 mg to about 10.67 mg,and about 10.67 mg to about 15.13 mg.

Embodiment 34. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein the amounts of two of the active ingredients areselected from: citric acid is present in an amount selected from: about101 mg to about 354 mg, about 101 mg to about 178 mg, about 178 mg toabout 699 mg, about 178 mg to about 354 mg, and about 352 mg to about699 mg; magnesium citrate is present in an amount selected from: about77 mg to about 202 mg, about 77 mg to about 151 mg, about 151 to about227 mg, about 151 to about 202 mg, and about 202 mg to about 227 mg;phytin is present in an amount selected from: about 3.06 mg to about 400mg, about 3.06 mg to about 201 mg, about 3.06 mg to about 100 mg, about100 mg to about 600 mg, about 100 mg to about 400 mg, about 100 mg toabout 201 mg, about 201 mg to about 600 mg, about 201 mg to about 400mg, and about 400 mg to about 600 mg; and pyridoxine is present in anamount selected from: about 0.23 mg to about 10.67 mg, about 0.23 mg toabout 5.95 mg, about 0.23 mg to about 2.68 mg, about 2.68 mg to about15.13 mg, about 2.68 mg to about 10.67 mg, about 2.68 mg to about 5.95mg, about 5.45 mg to about 15.13 mg, about 5.45 mg to about 10.67 mg,and about 10.67 mg to about 15.13 mg.

Embodiment 35. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein the amounts of 3 of the ingredients are selectedfrom: citric acid is present in an amount selected from: about 101 mg toabout 354 mg, about 101 mg to about 178 mg, about 178 mg to about 699mg, about 178 mg to about 354 mg, and about 352 mg to about 699 mg;magnesium citrate is present in an amount selected from: about 77 mg toabout 202 mg, about 77 mg to about 151 mg, about 151 to about 227 mg,about 151 to about 202 mg, and about 202 mg to about 227 mg; phytin ispresent in an amount selected from: about 3.06 mg to about 400 mg, about3.06 mg to about 201 mg, about 3.06 mg to about 100 mg, about 100 mg toabout 600 mg, about 100 mg to about 400 mg, about 100 mg to about 201mg, about 201 mg to about 600 mg, about 201 mg to about 400 mg, andabout 400 mg to about 600 mg; and pyridoxine is present in an amountselected from: about 0.23 mg to about 10.67 mg, about 0.23 mg to about5.95 mg, about 0.23 mg to about 2.68 mg, about 2.68 mg to about 15.13mg, about 2.68 mg to about 10.67 mg, about 2.68 mg to about 5.95 mg,about 5.45 mg to about 15.13 mg, about 5.45 mg to about 10.67 mg, andabout 10.67 mg to about 15.13 mg.

Embodiment 36. The oral dosage form or plurality of dosage forms ofembodiment 22, wherein citric acid is present in an amount of about 350mg; magnesium citrate is present in an amount of about 150 mg; phytin ispresent in an amount of about 200 mg; and pyridoxine is present in anamount of about 5 mg.

Embodiment 37. The oral dosage form or a plurality of dosage formsaccording to any one of embodiments 22 to 36, wherein the percentinhibition of calcium oxalate crystal formation by the combination ofactive ingredients is greater than about 89%.

Embodiment 38. The oral dosage form or plurality of dosage formsaccording to embodiment 37, where the percent inhibition is greater thanabout 94%.

Embodiment 39. The oral dosage form or plurality of dosage formsaccording to embodiment 38 where the percent inhibition is greater thanabout 98%.

Embodiment 40. An oral dosage form or a plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate, phytin,and musa.

Embodiment 41. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein citric acid is present in an amount of about 102mg to about 1052 mg.

Embodiment 42. The oral dosage form or plurality of dosage formsaccording to embodiment 41 wherein citric acid is present in an amountselected from: about 102 mg to about 700 mg, about 102 mg to about 352mg, about 102 mg to about 177 mg, about 177 mg to about 1052 mg, about177 mg to about 700 mg, about 177 mg to about 352 mg, about 351 mg toabout 1052 mg, about 351 mg to about 700 mg, and about 700 mg to about1052 mg.

Embodiment 43. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein magnesium citrate is present in an amount ofabout 2.32 mg to about 201 mg.

Embodiment 44. The oral dosage form or plurality of dosage formsaccording to embodiment 43 wherein magnesium citrate is present in anamount selected from: about 2.32 mg to about 201 mg, about 2.32 mg toabout 151 mg, about 2.32 to about 77 mg, about 77 to about 201 mg, about77 to about 151 mg, and about 150 mg to about 201 mg.

Embodiment 45. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein phytin is present in an amount of about 100 mg toabout 600 mg.

Embodiment 46. The oral dosage form or plurality of dosage formsaccording to embodiment 45 wherein phytin is present in an amountselected from: about 100 mg to about 401 mg, about 100 mg to about 202mg, about 201 mg to about 600 mg, about 201 mg to about 401 mg, andabout 401 mg to about 600 mg.

Embodiment 47. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein musa is present in an amount of about 1.51 mg toabout 251 mg.

Embodiment 48. The oral dosage form or plurality of dosage formsaccording to embodiment 47 wherein musa is present in an amount selectedfrom: about 1.51 mg to about 167 mg, about 1.51 mg to about 86 mg, about1.51 mg to about 41 mg, about 41 mg to about 251 mg, about 41 mg toabout 167 mg, about 41 mg to about 86 mg, about 86 mg to about 251 mg,about 86 mg to about 167, and about 167 mg to about 251 mg.

Embodiment 49. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein citric acid is present in an amount of about 102mg to about 1052 mg, magnesium citrate is present in an amount of about2.32 mg to about 201 mg, phytin is present in an amount of about 100 mgto about 600 mg, and musa is present in an amount of about 1.51 mg toabout 251 mg.

Embodiment 50. The oral dosage form or plurality of dosage formsaccording to embodiment 49 wherein citric acid is present in an amountselected from: about 102 mg to about 700 mg, about 102 mg to about 352mg, about 102 mg to about 177 mg, about 177 mg to about 1052 mg, about177 mg to about 700 mg, about 177 mg to about 352 mg, about 351 mg toabout 1052 mg, about 351 mg to about 700 mg, and about 700 mg to about1052 mg; magnesium citrate is present in an amount selected from: about2.32 mg to about 201 mg, about 2.32 mg to about 151 mg, about 2.32 toabout 77 mg, about 77 to about 201 mg, about 77 to about 151 mg, andabout 150 mg to about 201 mg; phytin is present in an amount selectedfrom: about 100 mg to about 401 mg, about 100 mg to about 202 mg, about201 mg to about 600 mg, about 201 mg to about 401 mg, and about 401 mgto about 600 mg; and musa is present in an amount selected from: about1.51 mg to about 167 mg, about 1.51 mg to about 86 mg, about 1.51 mg toabout 41 mg, about 41 mg to about 251 mg, about 41 mg to about 167 mg,about 41 mg to about 86 mg, about 86 mg to about 251 mg, about 86 mg toabout 167, and about 167 mg to about 251 mg.

Embodiment 51. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein the amount of one of the active ingredients isselected from: citric acid is present in an amount selected from: about102 mg to about 700 mg, about 102 mg to about 352 mg, about 102 mg toabout 177 mg, about 177 mg to about 1052 mg, about 177 mg to about 700mg, about 177 mg to about 352 mg, about 351 mg to about 1052 mg, about351 mg to about 700 mg, and about 700 mg to about 1052 mg; magnesiumcitrate is present in an amount selected from: about 2.32 mg to about201 mg, about 2.32 mg to about 151 mg, about 2.32 to about 77 mg, about77 to about 201 mg, about 77 to about 151 mg, and about 150 mg to about201 mg; phytin is present in an amount selected from: about 100 mg toabout 401 mg, about 100 mg to about 202 mg, about 201 mg to about 600mg, about 201 mg to about 401 mg, and about 401 mg to about 600 mg; andmusa is present in an amount selected from: about 1.51 mg to about 167mg, about 1.51 mg to about 86 mg, about 1.51 mg to about 41 mg, about 41mg to about 251 mg, about 41 mg to about 167 mg, about 41 mg to about 86mg, about 86 mg to about 251 mg, about 86 mg to about 167, and about 167mg to about 251 mg.

Embodiment 52. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein the amounts of two of the active ingredients areselected from: citric acid is present in an amount selected from: about102 mg to about 700 mg, about 102 mg to about 352 mg, about 102 mg toabout 177 mg, about 177 mg to about 1052 mg, about 177 mg to about 700mg, about 177 mg to about 352 mg, about 351 mg to about 1052 mg, about351 mg to about 700 mg, and about 700 mg to about 1052 mg; magnesiumcitrate is present in an amount selected from: about 2.32 mg to about201 mg, about 2.32 mg to about 151 mg, about 2.32 to about 77 mg, about77 to about 201 mg, about 77 to about 151 mg, and about 150 mg to about201 mg; phytin is present in an amount selected from: about 100 mg toabout 401 mg, about 100 mg to about 202 mg, about 201 mg to about 600mg, about 201 mg to about 401 mg, and about 401 mg to about 600 mg; andmusa is present in an amount selected from: about 1.51 mg to about 167mg, about 1.51 mg to about 86 mg, about 1.51 mg to about 41 mg, about 41mg to about 251 mg, about 41 mg to about 167 mg, about 41 mg to about 86mg, about 86 mg to about 251 mg, about 86 mg to about 167, and about 167mg to about 251 mg.

Embodiment 53. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein the amounts of 3 of the ingredients are selectedfrom: citric acid is present in an amount selected from: about 102 mg toabout 700 mg, about 102 mg to about 352 mg, about 102 mg to about 177mg, about 177 mg to about 1052 mg, about 177 mg to about 700 mg, about177 mg to about 352 mg, about 351 mg to about 1052 mg, about 351 mg toabout 700 mg, and about 700 mg to about 1052 mg; magnesium citrate ispresent in an amount selected from: about 2.32 mg to about 201 mg, about2.32 mg to about 151 mg, about 2.32 to about 77 mg, about 77 to about201 mg, about 77 to about 151 mg, and about 150 mg to about 201 mg;phytin is present in an amount selected from: about 100 mg to about 401mg, about 100 mg to about 202 mg, about 201 mg to about 600 mg, about201 mg to about 401 mg, and about 401 mg to about 600 mg; and musa ispresent in an amount selected from: about 1.51 mg to about 167 mg, about1.51 mg to about 86 mg, about 1.51 mg to about 41 mg, about 41 mg toabout 251 mg, about 41 mg to about 167 mg, about 41 mg to about 86 mg,about 86 mg to about 251 mg, about 86 mg to about 167, and about 167 mgto about 251 mg.

Embodiment 54. The oral dosage form or plurality of dosage forms ofembodiment 40, wherein citric acid is present in an amount of about 350mg; magnesium citrate is present in an amount of about 150 mg; phytin ispresent in an amount of about 200 mg; and musa is present in an amountof about 250 mg.

Embodiment 55. The oral dosage form or a plurality of dosage formsaccording to any one of embodiments 40 to 54, wherein the percentinhibition of calcium oxalate crystal formation by the combination ofactive ingredients is greater than about 92%.

Embodiment 56. The oral dosage form or plurality of dosage formsaccording to embodiment 55, where the percent inhibition is greater thanabout 96%.

Embodiment 57. The oral dosage form or plurality of dosage formsaccording to embodiment 56 where the percent inhibition is greater thanabout 100%.

Embodiment 58. An oral dosage form or a plurality of dosage formscomprising as active ingredients citric acid, magnesium citrate,pyridoxine, and musa.

Embodiment 59. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein citric acid is present in an amount of about 101mg to about 1051 mg.

Embodiment 60. The oral dosage form or plurality of dosage formsaccording to embodiment 59 wherein citric acid is present in an amountselected from: about 101 mg to about 700 mg, about 101 mg to about 353mg, about 101 mg to about 176 mg, about 176 mg to about 1051 mg, about176 mg to about 700 mg, about 176 mg to about 353 mg, about 352 mg toabout 1051 mg, about 352 mg to about 700 mg, and about 700 mg to about1051 mg.

Embodiment 61. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein magnesium citrate is present in an amount ofabout 2.14 mg to about 226 mg.

Embodiment 62. The oral dosage form or plurality of dosage formsaccording to embodiment 61 wherein magnesium citrate is present in anamount selected from: about 2.14 mg to about 202 mg, about 2.14 mg toabout 153 mg, about 2.14 mg to about 77 mg, about 77 to about 226 mg,about 77 to about 202 mg, about 77 to about 153 mg, about 151 mg toabout 226 mg, about 151 mg to about 202 mg, and about 202 mg to about226 mg.

Embodiment 63. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein pyridoxine is present in an amount of about 0.25mg to about 10.23 mg.

Embodiment 64. The oral dosage form or plurality of dosage formsaccording to embodiment 63 wherein pyridoxine is present in an amountselected from: about 0.25 mg to about 5.95 mg, about 0.25 mg to about2.63 mg, about 2.63 mg to about 10.23 mg, about 2.63 mg to about 5.95mg, and about 5.41 mg to about 10.23 mg.

Embodiment 65. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein musa is present in an amount of about 41.02 mg toabout 252 mg.

Embodiment 66. The oral dosage form or plurality of dosage formsaccording to embodiment 65 wherein musa is present in an amount selectedfrom: about 41.02 mg to about 167 mg, about 41.02 mg to about 85 mg,about 85 mg to about 252 mg, about 85 mg to about 167 mg, and about 167mg to about 252 mg.

Embodiment 67. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein citric acid is present in an amount of about 101mg to about 1051 mg, magnesium citrate is present in an amount of about2.14 mg to about 226 mg, pyridoxine is present in an amount of about0.25 mg to about 10.23 mg, and musa is present in an amount of about41.02 mg to about 252 mg.

Embodiment 68. The oral dosage form or plurality of dosage formsaccording to embodiment 67 wherein citric acid is present in an amountselected from: about 101 mg to about 700 mg, about 101 mg to about 353mg, about 101 mg to about 176 mg, about 176 mg to about 1051 mg, about176 mg to about 700 mg, about 176 mg to about 353 mg, about 352 mg toabout 1051 mg, about 352 mg to about 700 mg, and about 700 mg to about1051 mg; magnesium citrate is present in an amount selected from: about2.14 mg to about 202 mg, about 2.14 mg to about 153 mg, about 2.14 mg toabout 77 mg, about 77 to about 226 mg, about 77 to about 202 mg, about77 to about 153 mg, about 151 mg to about 226 mg, about 151 mg to about202 mg, and about 202 mg to about 226 mg; pyridoxine is present in anamount selected from: about 0.25 mg to about 5.95 mg, about 0.25 mg toabout 2.63 mg, about 2.63 mg to about 10.23 mg, about 2.63 mg to about5.95 mg, and about 5.41 mg to about 10.23 mg; and musa is present in anamount selected from: about 41.02 mg to about 167 mg, about 41.02 mg toabout 85 mg, about 85 mg to about 252 mg, about 85 mg to about 167 mg,and about 167 mg to about 252 mg.

Embodiment 69. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein the amount of one of the active ingredients isselected from: citric acid is present in an amount selected from: about101 mg to about 700 mg, about 101 mg to about 353 mg, about 101 mg toabout 176 mg, about 176 mg to about 1051 mg, about 176 mg to about 700mg, about 176 mg to about 353 mg, about 352 mg to about 1051 mg, about352 mg to about 700 mg, and about 700 mg to about 1051 mg; magnesiumcitrate is present in an amount selected from: about 2.14 mg to about202 mg, about 2.14 mg to about 153 mg, about 2.14 mg to about 77 mg,about 77 to about 226 mg, about 77 to about 202 mg, about 77 to about153 mg, about 151 mg to about 226 mg, about 151 mg to about 202 mg, andabout 202 mg to about 226 mg; pyridoxine is present in an amountselected from: about 0.25 mg to about 5.95 mg, about 0.25 mg to about2.63 mg, about 2.63 mg to about 10.23 mg, about 2.63 mg to about 5.95mg, and about 5.41 mg to about 10.23 mg; and musa is present in anamount selected from: about 41.02 mg to about 167 mg, about 41.02 mg toabout 85 mg, about 85 mg to about 252 mg, about 85 mg to about 167 mg,and about 167 mg to about 252 mg.

Embodiment 70. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein the amounts of two of the active ingredients areselected from: citric acid is present in an amount selected from: about101 mg to about 700 mg, about 101 mg to about 353 mg, about 101 mg toabout 176 mg, about 176 mg to about 1051 mg, about 176 mg to about 700mg, about 176 mg to about 353 mg, about 352 mg to about 1051 mg, about352 mg to about 700 mg, and about 700 mg to about 1051 mg; magnesiumcitrate is present in an amount selected from: about 2.14 mg to about202 mg, about 2.14 mg to about 153 mg, about 2.14 mg to about 77 mg,about 77 to about 226 mg, about 77 to about 202 mg, about 77 to about153 mg, about 151 mg to about 226 mg, about 151 mg to about 202 mg, andabout 202 mg to about 226 mg; pyridoxine is present in an amountselected from: about 0.25 mg to about 5.95 mg, about 0.25 mg to about2.63 mg, about 2.63 mg to about 10.23 mg, about 2.63 mg to about 5.95mg, and about 5.41 mg to about 10.23 mg; and musa is present in anamount selected from: about 41.02 mg to about 167 mg, about 41.02 mg toabout 85 mg, about 85 mg to about 252 mg, about 85 mg to about 167 mg,and about 167 mg to about 252 mg.

Embodiment 71. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein the amounts of 3 of the ingredients are selectedfrom: citric acid is present in an amount selected from: about 101 mg toabout 700 mg, about 101 mg to about 353 mg, about 101 mg to about 176mg, about 176 mg to about 1051 mg, about 176 mg to about 700 mg, about176 mg to about 353 mg, about 352 mg to about 1051 mg, about 352 mg toabout 700 mg, and about 700 mg to about 1051 mg; magnesium citrate ispresent in an amount selected from: about 2.14 mg to about 202 mg, about2.14 mg to about 153 mg, about 2.14 mg to about 77 mg, about 77 to about226 mg, about 77 to about 202 mg, about 77 to about 153 mg, about 151 mgto about 226 mg, about 151 mg to about 202 mg, and about 202 mg to about226 mg; pyridoxine is present in an amount selected from: about 0.25 mgto about 5.95 mg, about 0.25 mg to about 2.63 mg, about 2.63 mg to about10.23 mg, about 2.63 mg to about 5.95 mg, and about 5.41 mg to about10.23 mg; and musa is present in an amount selected from: about 41.02 mgto about 167 mg, about 41.02 mg to about 85 mg, about 85 mg to about 252mg, about 85 mg to about 167 mg, and about 167 mg to about 252 mg.

Embodiment 72. The oral dosage form or plurality of dosage forms ofembodiment 58, wherein citric acid is present in an amount of about 350mg; magnesium citrate is present in an amount of about 150 mg;pyridoxine is present in an amount of about 5 mg; and musa is present inan amount of about 250 mg.

Embodiment 73. The oral dosage form or a plurality of dosage formsaccording to any one of embodiments 58 to 72, wherein the percentinhibition of calcium oxalate crystal formation by the combination ofactive ingredients is greater than about 59%.

Embodiment 74. The oral dosage form or plurality of dosage formsaccording to embodiment 73, where the percent inhibition is greater thanabout 62%.

Embodiment 75. The oral dosage form or plurality of dosage formsaccording to embodiment 74 where the percent inhibition is greater thanabout 66%.

Embodiment 76. An oral dosage form or a plurality of dosage formscomprising as active ingredients citric acid, phytin, pyridoxine, andmusa.

Embodiment 77. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein citric acid is present in an amount of about 101mg to less than about 700 mg.

Embodiment 78. The oral dosage form or plurality of dosage formsaccording to embodiment 77 wherein citric acid is present in an amountselected from: about 101 mg to about 353 mg, about 101 mg to about 177mg, about 177 mg to less than about 700 mg, about 177 mg to about 353mg, and about 352 mg to less than about 700 mg.

Embodiment 79. The oral dosage form or plurality of dosage forms ofembodiment 77, wherein citric acid is present in an amount of about 101mg to about 353 mg.

Embodiment 80. The oral dosage form or plurality of dosage formsaccording to embodiment 79 wherein citric acid is present in an amountselected from: about 101 mg to about 353 mg, about 101 mg to about 177mg, and about 177 mg to about 353 mg.

Embodiment 81. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein phytin is present in an amount of about 101 mg toabout 600 mg.

Embodiment 82. The oral dosage form or plurality of dosage formsaccording to embodiment 81 wherein phytin is present in an amountselected from: about 101 mg to about 400 mg, about 101 mg to about 203mg, about 202 mg to about 600 mg, about 202 to about 400 mg, and about400 to about 600 mg.

Embodiment 83. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein pyridoxine is present in an amount of about 0.23mg to about 15.12 mg.

Embodiment 84. The oral dosage form or plurality of dosage formsaccording to embodiment 83 wherein pyridoxine is present in an amountselected from: about 0.23 mg to about 10.20 mg, about 0.23 mg to about6.00 mg, about 0.23 mg to about 2.69 mg, about 2.69 mg to about 15.12mg, about 2.69 mg to about 10.20 mg, about 2.69 mg to about 6.00 mg,about 5.45 mg to about 15.12 mg, about 5.45 mg to about 10.20 mg, andabout 10.20 mg to about 15.12 mg.

Embodiment 85. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein musa is present in an amount of about 1.46 mg toabout 252 mg.

Embodiment 86. The oral dosage form or plurality of dosage formsaccording to embodiment 85 wherein musa is present in an amount selectedfrom: about 1.46 mg to about 167 mg, about 1.46 mg to about 86 mg, about1.46 mg to about 41 mg, about 41 mg to about 252 mg, about 41 mg toabout 167 mg, about 41 mg to about 86 mg, about 86 mg to about 252 mg,about 86 mg to about 167 mg, and about 167 mg to about 252 mg.

Embodiment 87. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein citric acid is present in an amount of about 101mg to less than about 700 mg, phytin is present in an amount of about101 mg to about 600 mg, pyridoxine is present in an amount of about 0.23mg to about 15.12 mg, and musa is present in an amount of about 1.46 mgto about 252 mg.

Embodiment 88. The oral dosage form or plurality of dosage forms ofembodiment 87, wherein citric acid is present in an amount of about 101mg to about 353 mg.

Embodiment 89. The oral dosage form or plurality of dosage formsaccording to embodiment 87 wherein citric acid is present in an amountselected from: about 101 mg to about 353 mg, about 101 mg to about 177mg, about 177 mg to less than about 700 mg, about 177 mg to about 353mg, and about 352 mg to less than about 700 mg; phytin is present in anamount selected from: about 101 mg to about 400 mg, about 101 mg toabout 203 mg, about 202 mg to about 600 mg, about 202 to about 400 mg,and about 400 to about 600 mg; pyridoxine is present in an amountselected from: about 0.23 mg to about 10.20 mg, about 0.23 mg to about6.00 mg, about 0.23 mg to about 2.69 mg, about 2.69 mg to about 15.12mg, about 2.69 mg to about 10.20 mg, about 2.69 mg to about 6.00 mg,about 5.45 mg to about 15.12 mg, about 5.45 mg to about 10.20 mg, andabout 10.20 mg to about 15.12 mg; and musa is present in an amountselected from: about 1.46 mg to about 167 mg, about 1.46 mg to about 86mg, about 1.46 mg to about 41 mg, about 41 mg to about 252 mg, about 41mg to about 167 mg, about 41 mg to about 86 mg, about 86 mg to about 252mg, about 86 mg to about 167 mg, and about 167 mg to about 252 mg.

Embodiment 90. The oral dosage form or plurality of dosage formsaccording to embodiment 89 wherein citric acid is present in an amountselected from: about 101 mg to about 353 mg, about 101 mg to about 177mg, and about 177 mg to about 353 mg

Embodiment 91. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein the amount of one of the active ingredients isselected from: citric acid is present in an amount selected from: about101 mg to about 353 mg, about 101 mg to about 177 mg, about 177 mg toless than about 700 mg, about 177 mg to about 353 mg, and about 352 mgto less than about 700 mg; phytin is present in an amount selected from:about 101 mg to about 400 mg, about 101 mg to about 203 mg, about 202 mgto about 600 mg, about 202 to about 400 mg, and about 400 to about 600mg; pyridoxine is present in an amount selected from: about 0.23 mg toabout 10.20 mg, about 0.23 mg to about 6.00 mg, about 0.23 mg to about2.69 mg, about 2.69 mg to about 15.12 mg, about 2.69 mg to about 10.20mg, about 2.69 mg to about 6.00 mg, about 5.45 mg to about 15.12 mg,about 5.45 mg to about 10.20 mg, and about 10.20 mg to about 15.12 mg;and musa is present in an amount selected from: about 1.46 mg to about167 mg, about 1.46 mg to about 86 mg, about 1.46 mg to about 41 mg,about 41 mg to about 252 mg, about 41 mg to about 167 mg, about 41 mg toabout 86 mg, about 86 mg to about 252 mg, about 86 mg to about 167 mg,and about 167 mg to about 252 mg.

Embodiment 92. The oral dosage form or plurality of dosage formsaccording to embodiment 91 wherein citric acid is present in an amountselected from: about 101 mg to about 353 mg, about 101 mg to about 177mg, and about 177 mg to about 353 mg.

Embodiment 93. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein the amounts of two of the active ingredients areselected from: citric acid is present in an amount selected from: about101 mg to about 353 mg, about 101 mg to about 177 mg, about 177 mg toless than about 700 mg, about 177 mg to about 353 mg, and about 352 mgto less than about 700 mg; phytin is present in an amount selected from:about 101 mg to about 400 mg, about 101 mg to about 203 mg, about 202 mgto about 600 mg, about 202 to about 400 mg, and about 400 to about 600mg; pyridoxine is present in an amount selected from: about 0.23 mg toabout 10.20 mg, about 0.23 mg to about 6.00 mg, about 0.23 mg to about2.69 mg, about 2.69 mg to about 15.12 mg, about 2.69 mg to about 10.20mg, about 2.69 mg to about 6.00 mg, about 5.45 mg to about 15.12 mg,about 5.45 mg to about 10.20 mg, and about 10.20 mg to about 15.12 mg;and musa is present in an amount selected from: about 1.46 mg to about167 mg, about 1.46 mg to about 86 mg, about 1.46 mg to about 41 mg,about 41 mg to about 252 mg, about 41 mg to about 167 mg, about 41 mg toabout 86 mg, about 86 mg to about 252 mg, about 86 mg to about 167 mg,and about 167 mg to about 252 mg

Embodiment 94. The oral dosage form or plurality of dosage formsaccording to embodiment 93 wherein citric acid is present in an amountselected from: about 101 mg to about 353 mg, about 101 mg to about 177mg, and about 177 mg to about 353 mg.

Embodiment 95. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein the amounts of 3 of the ingredients are selectedfrom: citric acid is present in an amount selected from: about 101 mg toabout 353 mg, about 101 mg to about 177 mg, about 177 mg to less thanabout 700 mg, about 177 mg to about 353 mg, and about 352 mg to lessthan about 700 mg; phytin is present in an amount selected from: about101 mg to about 400 mg, about 101 mg to about 203 mg, about 202 mg toabout 600 mg, about 202 to about 400 mg, and about 400 to about 600 mg;pyridoxine is present in an amount selected from: about 0.23 mg to about10.20 mg, about 0.23 mg to about 6.00 mg, about 0.23 mg to about 2.69mg, about 2.69 mg to about 15.12 mg, about 2.69 mg to about 10.20 mg,about 2.69 mg to about 6.00 mg, about 5.45 mg to about 15.12 mg, about5.45 mg to about 10.20 mg, and about 10.20 mg to about 15.12 mg; andmusa is present in an amount selected from: about 1.46 mg to about 167mg, about 1.46 mg to about 86 mg, about 1.46 mg to about 41 mg, about 41mg to about 252 mg, about 41 mg to about 167 mg, about 41 mg to about 86mg, about 86 mg to about 252 mg, about 86 mg to about 167 mg, and about167 mg to about 252 mg.

Embodiment 96. The oral dosage form or plurality of dosage formsaccording to embodiment 95 wherein citric acid is present in an amountselected from: about 101 mg to about 353 mg, about 101 mg to about 177mg, and about 177 mg to about 353 mg.

Embodiment 97. The oral dosage form or plurality of dosage forms ofembodiment 76, wherein citric acid is present in an amount of about 350mg; phytin is present in an amount of about 200 mg; pyridoxine ispresent in an amount of about 5 mg; and musa is present in an amount ofabout 250 mg.

Embodiment 98. The oral dosage form or a plurality of dosage formsaccording to any one of embodiments 76 to 97, wherein the percentinhibition of calcium oxalate crystal formation by the combination ofactive ingredients is greater than about 88%.

Embodiment 99. The oral dosage form or plurality of dosage formsaccording to embodiment 98, where the percent inhibition is greater thanabout 100%.

Embodiment 100. The oral dosage form or plurality of dosage formsaccording to embodiment 99 where the percent inhibition is greater thanabout 108%.

Embodiment 101. An oral dosage form or a plurality of dosage formscomprising as active ingredients magnesium citrate, phytin, pyridoxine,and musa.

Embodiment 102. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein magnesium citrate is present in an amount ofabout 2.03 mg to about 203 mg.

Embodiment 103. The oral dosage form or plurality of dosage formsaccording to embodiment 102 wherein magnesium citrate is present in anamount selected from: about 2.03 mg to about 151 mg, about 2.03 mg toabout 77 mg, about 77 mg to about 203 mg, about 77 mg to about 151 mg,and about 151 mg to about 203 mg.

Embodiment 104. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein phytin is present in an amount of about 100 mgto about 600 mg.

Embodiment 105. The oral dosage form or plurality of dosage formsaccording to embodiment 104 wherein phytin is present in an amountselected from: about 100 mg to about 475 mg, 100 mg to about 400 mg,about 100 mg to about 202 mg, about 201 mg to about 600 mg, about 201 mgto about 475 mg, about 201 to about 400 mg, about 400 mg to about 600mg, about 400 to about 475 mg, and about 475 mg to about 600 mg.

Embodiment 106. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein pyridoxine is present in an amount of about 0.22mg to about 15.1 mg.

Embodiment 107. The oral dosage form or plurality of dosage formsaccording to embodiment 106 wherein pyridoxine is present in an amountselected from: about 0.22 mg to about 10.11 mg, about 0.22 mg to about6.01 mg, about 0.22 mg to about 2.69 mg, about 2.69 mg to about 15.1 mg,about 2.69 mg to about 10.11 mg, about 2.69 mg to about 6.01 mg, about5.4 mg to about 15.1 mg, about 5.4 mg to about 10.11 mg, and about 10.11mg to about 15.1 mg.

Embodiment 108. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein musa is present in an amount of about 1.46 mg toabout 252 mg.

Embodiment 109. The oral dosage form or plurality of dosage formsaccording to embodiment 108 wherein musa is present in an amountselected from: about 1.46 mg to about 168 mg, about 1.46 mg to about 85mg, about 1.46 mg to about 42 mg, about 42 mg to about 252 mg, about 42mg to about 168 mg, about 42 mg to about 85 mg, about 85 mg to about 252mg, about 85 mg to about 168 mg, and about 168 mg to about 252 mg.

Embodiment 110. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein magnesium citrate is present in an amount ofabout 2.03 mg to about 203 mg, phytin is present in an amount of about100 mg to about 600 mg, pyridoxine is present in an amount of about 0.22mg to about 15.1 mg, and musa is present in an amount of about 1.46 mgto about 252 mg.

Embodiment 111. The oral dosage form or plurality of dosage formsaccording to embodiment 110 wherein magnesium citrate is present in anamount selected from: about 2.03 mg to about 77 mg, about 2.03 mg toabout 151 mg, about 77 mg to about 151 mg, about 77 mg to about 203 mg,and about 151 mg to about 203 mg; phytin is present in an amountselected from: 100 mg to about 475 mg, 100 mg to about 400 mg, about 100mg to about 202 mg, about 201 mg to about 600 mg, about 201 mg to about475 mg, about 201 to about 400 mg, about 400 mg to about 600 mg, about400 to about 475 mg, and about 475 mg to about 600 mg; pyridoxine ispresent in an amount selected from: about 0.22 mg to about 10.11 mg,about 0.22 mg to about 6.01 mg, about 0.22 mg to about 2.69 mg, about2.69 mg to about 15.1 mg, about 2.69 mg to about 10.11 mg, about 2.69 mgto about 6.01 mg, about 5.4 mg to about 15.1 mg, about 5.4 mg to about10.1120 mg, and about 10.11 mg to about 15.1 mg; and musa is present inan amount selected from: about 1.46 mg to about 168 mg, about 1.46 mg toabout 85 mg, about 1.46 mg to about 42 mg, about 41 mg to about 252 mg,about 41 mg to about 168 mg, about 41 mg to about 85 mg, about 85 mg toabout 252 mg, about 85 mg to about 168 mg, and about 168 mg to about 252mg.

Embodiment 112. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein the amount of one of the active ingredients isselected from: magnesium citrate is present in an amount selected from:about 2.03 mg to about 77 mg, about 2.03 mg to about 151 mg, about 77 mgto about 151 mg, about 77 mg to about 203 mg, and about 151 mg to about203 mg; phytin is present in an amount selected from: 100 mg to about475 mg, 100 mg to about 400 mg, about 100 mg to about 202 mg, about 201mg to about 600 mg, about 201 mg to about 475 mg, about 201 to about 400mg, about 400 mg to about 600 mg, about 400 to about 475 mg, and about475 mg to about 600 mg; pyridoxine is present in an amount selectedfrom: about 0.22 mg to about 10.11 mg, about 0.22 mg to about 6.01 mg,about 0.22 mg to about 2.69 mg, about 2.69 mg to about 15.1 mg, about2.69 mg to about 10.11 mg, about 2.69 mg to about 6.01 mg, about 5.4 mgto about 15.1 mg, about 5.4 mg to about 10.1120 mg, and about 10.11 mgto about 15.1 mg; and musa is present in an amount selected from: about1.46 mg to about 168 mg, about 1.46 mg to about 85 mg, about 1.46 mg toabout 42 mg, about 41 mg to about 252 mg, about 41 mg to about 168 mg,about 41 mg to about 85 mg, about 85 mg to about 252 mg, about 85 mg toabout 168 mg, and about 168 mg to about 252 mg.

Embodiment 113. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein the amounts of two of the active ingredients areselected from: magnesium citrate is present in an amount selected from:about 2.03 mg to about 77 mg, about 2.03 mg to about 151 mg, about 77 mgto about 151 mg, about 77 mg to about 203 mg, and about 151 mg to about203 mg; phytin is present in an amount selected from: 100 mg to about475 mg, 100 mg to about 400 mg, about 100 mg to about 202 mg, about 201mg to about 600 mg, about 201 mg to about 475 mg, about 201 to about 400mg, about 400 mg to about 600 mg, about 400 to about 475 mg, and about475 mg to about 600 mg; pyridoxine is present in an amount selectedfrom: about 0.22 mg to about 10.11 mg, about 0.22 mg to about 6.01 mg,about 0.22 mg to about 2.69 mg, about 2.69 mg to about 15.1 mg, about2.69 mg to about 10.11 mg, about 2.69 mg to about 6.01 mg, about 5.4 mgto about 15.1 mg, about 5.4 mg to about 10.1120 mg, and about 10.11 mgto about 15.1 mg; and musa is present in an amount selected from: about1.46 mg to about 168 mg, about 1.46 mg to about 85 mg, about 1.46 mg toabout 42 mg, about 41 mg to about 252 mg, about 41 mg to about 168 mg,about 41 mg to about 85 mg, about 85 mg to about 252 mg, about 85 mg toabout 168 mg, and about 168 mg to about 252 mg.

Embodiment 114. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein the amounts of 3 of the ingredients are selectedfrom: magnesium citrate is present in an amount selected from: about2.03 mg to about 77 mg, about 2.03 mg to about 151 mg, about 77 mg toabout 151 mg, about 77 mg to about 203 mg, and about 151 mg to about 203mg; phytin is present in an amount selected from: 100 mg to about 475mg, 100 mg to about 400 mg, about 100 mg to about 202 mg, about 201 mgto about 600 mg, about 201 mg to about 475 mg, about 201 to about 400mg, about 400 mg to about 600 mg, about 400 to about 475 mg, and about475 mg to about 600 mg; pyridoxine is present in an amount selectedfrom: about 0.22 mg to about 10.11 mg, about 0.22 mg to about 6.01 mg,about 0.22 mg to about 2.69 mg, about 2.69 mg to about 15.1 mg, about2.69 mg to about 10.11 mg, about 2.69 mg to about 6.01 mg, about 5.4 mgto about 15.1 mg, about 5.4 mg to about 10.1120 mg, and about 10.11 mgto about 15.1 mg; and musa is present in an amount selected from: about1.46 mg to about 168 mg, about 1.46 mg to about 85 mg, about 1.46 mg toabout 42 mg, about 41 mg to about 252 mg, about 41 mg to about 168 mg,about 41 mg to about 85 mg, about 85 mg to about 252 mg, about 85 mg toabout 168 mg, and about 168 mg to about 252 mg.

Embodiment 115. The oral dosage form or plurality of dosage forms ofembodiment 101, wherein magnesium citrate is present in an amount ofabout 250 mg; phytin is present in an amount of about 200 mg; pyridoxineis present in an amount of about 5 mg; and musa is present in an amountof about 250 mg.

Embodiment 116. The oral dosage form or a plurality of dosage formsaccording to any one of embodiments 101 to 115, wherein the percentinhibition of calcium oxalate crystal formation by the combination ofactive ingredients is greater than about 99%.

Embodiment 117. The oral dosage form or plurality of dosage formsaccording to embodiment 116, where the percent inhibition is greaterthan about 104%.

Embodiment 118. The oral dosage form or plurality of dosage formsaccording to embodiment 117 where the percent inhibition is greater thanabout 106%.

Embodiment 119. An oral dosage form or a plurality of dosage formscomprising four ingredients selected from citric acid, magnesiumcitrate, phytin, pyridoxine, and musa.

Embodiment 120. The oral dosage form or plurality of dosage formsaccording to embodiment 119 selected from: (a) an oral dosage form orplurality of dosage forms wherein citric acid is present in an amount ofabout 101 mg to about 699 mg, magnesium citrate is present in an amountof about 77 mg to about 227 mg, phytin is present in an amount of about3.06 mg to about 600 mg, and pyridoxine is present in an amount of about0.23 mg to about 15.13 mg; (b) an oral dosage form or plurality ofdosage forms wherein citric acid is present in an amount of about 102 mgto about 1052 mg, magnesium citrate is present in an amount of about2.32 mg to about 201 mg, phytin is present in an amount of about 100 mgto about 600 mg, and musa is present in an amount of about 1.51 mg toabout 251 mg; (c) an oral dosage form or plurality of dosage formswherein citric acid is present in an amount of about 101 mg to about1051 mg, magnesium citrate is present in an amount of about 2.14 mg toabout 226 mg, pyridoxine is present in an amount of about 0.25 mg toabout 10.23 mg, and musa is present in an amount of about 41 mg to about252 mg; (d) an oral dosage form or plurality of dosage forms whereincitric acid is present in an amount of about 101 mg to less than about700 mg, phytin is present in an amount of about 101 mg to about 600 mg,pyridoxine is present in an amount of about 0.23 mg to about 15.12 mg,and musa is present in an amount of about 1.46 mg to about 252 mg; and(e) an oral dosage form or plurality of dosage forms wherein magnesiumcitrate is present in an amount of about 2.03 mg to about 203 mg, phytinis present in an amount of about 100 mg to about 600 mg, pyridoxine ispresent in an amount of about 0.22 mg to about 15.1 mg, and musa ispresent in an amount of about 1.46 mg to about 252 mg.

Embodiment 121. The oral dosage form or plurality of dosage formsaccording to embodiment 119 or 120, wherein citric acid is present in anamount of about 101 mg to about 699 mg, magnesium citrate is present inan amount of about 77 mg to about 227 mg, phytin is present in an amountof about 3.06 mg to about 600 mg, and pyridoxine is present in an amountof about 0.23 mg to about 15.13 mg.

Embodiment 122. The oral dosage form or plurality of dosage forms ofembodiment 121, wherein citric acid is present in an amount of about 350mg; magnesium citrate is present in an amount of about 150 mg; phytin ispresent in an amount of about 200 mg; and pyridoxine is present in anamount of about 5 mg.

Embodiment 123. The oral dosage form or a plurality of dosage formsaccording to embodiment 121 or 122, wherein the percent inhibition ofcalcium oxalate crystal formation by the combination of activeingredients is greater than about 89%.

Embodiment 124. The oral dosage form or plurality of dosage formsaccording to embodiment 123, where the percent inhibition is greaterthan about 94%.

Embodiment 125. The oral dosage form or plurality of dosage formsaccording to embodiment 125 where the percent inhibition is greater thanabout 98%.

Embodiment 126. The oral dosage form or plurality of dosage formsaccording to embodiment 119 or 120 wherein citric acid is present in anamount of about 102 mg to about 1052 mg, magnesium citrate is present inan amount of about 2.32 mg to about 201 mg, phytin is present in anamount of about 100 mg to about 600 mg, and musa is present in an amountof about 1.51 mg to about 251 mg.

Embodiment 127. The oral dosage form or plurality of dosage forms ofembodiment 126, wherein citric acid is present in an amount of about 350mg; magnesium citrate is present in an amount of about 150 mg; phytin ispresent in an amount of about 200 mg; and musa is present in an amountof about 250 mg.

Embodiment 128. The oral dosage form or a plurality of dosage formsaccording to embodiments 126 or 127, wherein the percent inhibition ofcalcium oxalate crystal formation by the combination of activeingredients is greater than about 92%.

Embodiment 129. The oral dosage form or plurality of dosage formsaccording to embodiment 128, where the percent inhibition is greaterthan about 96%.

Embodiment 130. The oral dosage form or plurality of dosage formsaccording to embodiment 129 where the percent inhibition is greater thanabout 100%.

Embodiment 131. The oral dosage form or plurality of dosage formsaccording to embodiment 119 or 120 wherein citric acid is present in anamount of about 101 mg to about 1051 mg, magnesium citrate is present inan amount of about 2.14 mg to about 226 mg, pyridoxine is present in anamount of about 0.25 mg to about 10.23 mg, and musa is present in anamount of about 41 mg to about 252 mg.

Embodiment 132. The oral dosage form or plurality of dosage forms ofembodiment 131, wherein citric acid is present in an amount of about 350mg; magnesium citrate is present in an amount of about 150 mg;pyridoxine is present in an amount of about 5 mg; and musa is present inan amount of about 250 mg.

Embodiment 133. The oral dosage form or a plurality of dosage formsaccording to embodiment 131 or 132, wherein the percent inhibition ofcalcium oxalate crystal formation by the combination of activeingredients is greater than about 59%.

Embodiment 134. The oral dosage form or plurality of dosage formsaccording to embodiment 133, where the percent inhibition is greaterthan about 62%.

Embodiment 135. The oral dosage form or plurality of dosage formsaccording to embodiment 134 where the percent inhibition is greater thanabout 66%.

Embodiment 136. The oral dosage form or plurality of dosage formsaccording to embodiment 119 or 120 wherein citric acid is present in anamount of about 101 mg to less than about 700 mg, phytin is present inan amount of about 101 mg to about 600 mg, pyridoxine is present in anamount of about 0.23 mg to about 15.12 mg, and musa is present in anamount of about 1.46 mg to about 252 mg.

Embodiment 137. The oral dosage form or plurality of dosage forms ofembodiment 136, wherein citric acid is present in an amount of about 101mg to about 353 mg.

Embodiment 138. The oral dosage form or plurality of dosage forms ofembodiment 136 or 137, wherein citric acid is present in an amount ofabout 350 mg; phytin is present in an amount of about 200 mg; pyridoxineis present in an amount of about 5 mg; and musa is present in an amountof about 250 mg.

Embodiment 139. The oral dosage form or a plurality of dosage formsaccording to any one of embodiments 136 to 138, wherein the percentinhibition of calcium oxalate crystal formation by the combination ofactive ingredients is greater than about 88%.

Embodiment 140. The oral dosage form or plurality of dosage formsaccording to embodiment 139, where the percent inhibition is greaterthan about 100%.

Embodiment 141. The oral dosage form or plurality of dosage formsaccording to embodiment 140 where the percent inhibition is greater thanabout 108%.

Embodiment 142. The oral dosage form or plurality of dosage formsaccording to embodiment 119 or 120 wherein magnesium citrate is presentin an amount of about 2.03 mg to about 203 mg, phytin is present in anamount of about 100 mg to about 600 mg, pyridoxine is present in anamount of about 0.22 mg to about 15.1 mg, and musa is present in anamount of about 1.46 mg to about 252 mg.

Embodiment 143. The oral dosage form or plurality of dosage forms ofembodiment 142, wherein magnesium citrate is present in an amount ofabout 250 mg; phytin is present in an amount of about 200 mg; pyridoxineis present in an amount of about 5 mg; and musa is present in an amountof about 250 mg.

Embodiment 144. The oral dosage form or a plurality of dosage formsaccording to any one of embodiments 142 or 143, wherein the percentinhibition of calcium oxalate crystal formation by the combination ofactive ingredients is greater than about 99%.

Embodiment 145. The oral dosage form or plurality of dosage formsaccording to embodiment 144, where the percent inhibition is greaterthan about 104%.

Embodiment 146. The oral dosage form or plurality of dosage formsaccording to embodiment 145, where the percent inhibition is greaterthan about 106%.

Embodiment 147. The oral dosage form or plurality of dosage formsaccording to embodiment 119 wherein one of the ingredients is selectedfrom: citric acid is present in an amount of about 101 mg to about 699mg, magnesium citrate is present in an amount of about 77 mg to about227 mg, phytin is present in an amount of about 3.06 mg to about 600 mg,and pyridoxine is present in an amount of about 0.23 mg to about 15.13mg.

Embodiment 148. The oral dosage form or plurality of dosage formsaccording to embodiment 119 wherein one of the ingredients is selectedfrom: citric acid is present in an amount of about 102 mg to about 1052mg, magnesium citrate is present in an amount of about 2.32 mg to about201 mg, phytin is present in an amount of about 100 mg to about 600 mg,and musa is present in an amount of about 1.51 mg to about 251 mg.

Embodiment 149. The oral dosage form or plurality of dosage formsaccording to embodiment 119 wherein one of the ingredients is selectedfrom: citric acid is present in an amount of about 101 mg to about 1051mg, magnesium citrate is present in an amount of about 2.14 mg to about226 mg, pyridoxine is present in an amount of about 0.25 mg to about10.23 mg, and musa is present in an amount of about 41 mg to about 252mg.

Embodiment 150. The oral dosage form or plurality of dosage formsaccording to embodiment 119 wherein one of the ingredients is selectedfrom: citric acid is present in an amount of about 101 mg to less thanabout 700 mg, phytin is present in an amount of about 101 mg to about600 mg, pyridoxine is present in an amount of about 0.23 mg to about15.12 mg, and musa is present in an amount of about 1.46 mg to about 252mg.

Embodiment 151. The oral dosage form or plurality of dosage formsaccording to embodiment 119 wherein one of the ingredients is selectedfrom: magnesium citrate is present in an amount of about 2.03 mg toabout 203 mg, phytin is present in an amount of about 100 mg to about600 mg, pyridoxine is present in an amount of about 0.22 mg to about15.1 mg, and musa is present in an amount of about 1.46 mg to about 252mg.

Embodiment 152. The oral dosage form or plurality of dosage formsaccording to any one of embodiments 147 to 151, wherein two ingredientsare selected.

Embodiment 153. The oral dosage form or plurality of dosage formsaccording to any one of embodiments 147 to 151, wherein threeingredients are selected.

Embodiment 154. The oral dosage form or plurality of dosage formsaccording to any one of embodiments 1 to 153, which is a single oraldosage form.

Embodiment 155. The oral dosage form or plurality of dosage formsaccording to any one of embodiments 1 to 154, comprising an oral dosageform in the form of a capsule.

Embodiment 156. The oral dosage form or plurality of dosage forms ofembodiment 155, wherein the capsule is a hard capsule.

Embodiment 157. The oral dosage form or plurality of dosage formsaccording to any one of embodiments 1 to 153, which is two oral dosageforms.

Embodiment 158. A method of treating or inhibiting formation of kidneystones comprising administering to a patient in need thereof the oraldosage form or plurality of dosage forms according to any one ofembodiments 1 to 157.

Embodiment 159. The method of embodiment 158, wherein the oral dosageform or plurality of dosage forms is administered once daily.

Embodiment 160. The method of embodiment 158, wherein the oral dosageform or plurality of dosage forms is administered twice daily.

Embodiment 161. The method of any one of embodiments 158 to 160, whereinthe oral dosage form or plurality of dosage forms comprises about 101 mgto about 700 mg citric acid; about 76 mg to about 226 mg magnesiumcitrate; about 3 mg to about 600 mg phytin; about 0.1 mg to about 15 mgpyridoxine; and about 1 mg to about 251 mg musa.

Embodiment 162. The method of embodiment 161, wherein the oral dosageform or plurality of dosage forms comprises about 350 mg citric acid,about 150 magnesium citrate, about 200 mg phytin, about 5 mg pyridoxine,and about 250 mg musa.

Embodiment 163. The method of any one of embodiments 158 to 162, whereinthe oral dosage form or plurality of dosage forms is an oral capsule ora plurality of oral capsules.

Embodiment 164. The method of any one of embodiments 158 to 163, whereinthe administering is without regard to food.

Embodiment 165. The method of any one of embodiments 157 to 162, whereinthe administering is with food.

Embodiment 166. The method of any one of embodiments 158 to 163, whereinthe administering is without food.

Embodiment 167. A method of inhibiting growth of calcium oxalatecrystals comprising contacting an aqueous solution comprising calciumoxalate with the oral dosage form or plurality of dosage forms accordingto any one of embodiments 1 to 157.

Embodiment 168. The method of embodiment 167, wherein the oral dosageform or plurality of dosage forms comprises about 101 mg to about 700 mgcitric acid; about 76 mg to about 226 mg magnesium citrate; about 3 mgto about 600 mg phytin; about 0.1 mg to about 15 mg pyridoxine; andabout 1 mg to about 251 mg musa.

In general, the invention may alternatively comprise, consist of, orconsist essentially of, any appropriate components herein disclosed. Theinvention may additionally, or alternatively, be formulated so as to bedevoid, or substantially free, of any components, materials,ingredients, adjuvants or species used in the prior art compositions orthat are otherwise not necessary to the achievement of the functionand/or objectives of the present invention. The endpoints of all rangesdirected to the same component or property are inclusive andindependently combinable (e.g., ranges of “less than or equal to 25 wt%, or 5 wt % to 20 wt %,” is inclusive of the endpoints and allintermediate values of the ranges of “5 wt % to 25 wt %,” etc.).Disclosure of a narrower range or more specific group in addition to abroader range is not a disclaimer of the broader range or larger group.

Reference throughout the specification to “some embodiments”, “anotherembodiment”, “an embodiment”, and so forth, means that a particularelement (e.g., feature, structure, and/or characteristic) described inconnection with the embodiment is included in at least one embodimentdescribed herein, and may or may not be present in other embodiments. Inaddition, it is to be understood that the described elements may becombined in any suitable manner in the various embodiments.

All cited patents, patent applications, and other references areincorporated herein by reference in their entirety. However, if a termin the present application contradicts or conflicts with a term in theincorporated reference, the term from the present application takesprecedence over the conflicting term from the incorporated reference

While particular embodiments have been described, alternatives,modifications, variations, improvements, and substantial equivalentsthat are or may be presently unforeseen may arise to applicants orothers skilled in the art. Accordingly, the appended claims as filed andas they may be amended are intended to embrace all such alternatives,modifications variations, improvements, and substantial equivalents.

1. An oral dosage form or a plurality of dosage forms comprising threeingredients selected from citric acid, magnesium citrate, phytin,pyridoxine, and musa.
 2. The oral dosage form or plurality of dosageforms according to claim 1 selected from: a) an oral dosage form orplurality of dosage forms comprising citric acid, magnesium citrate, andphytin; b) an oral dosage form or plurality of dosage forms comprisingcitric acid, phytin, and pyridoxine; c) an oral dosage form or pluralityof dosage forms comprising citric acid, pyridoxine, and musa; d) an oraldosage form or plurality of dosage forms comprising citric acid, phytin,and musa; e) an oral dosage form or plurality of dosage forms comprisingcitric acid, magnesium citrate, and pyridoxine; f) an oral dosage formor plurality of dosage forms comprising citric acid, magnesium citrate,and musa; g) an oral dosage form or plurality of dosage forms comprisingmagnesium citrate, phytin, and pyridoxine; h) an oral dosage form orplurality of dosage forms comprising magnesium citrate, pyridoxine, andmusa; i) an oral dosage form or plurality of dosage forms comprisingmagnesium citrate, phytin, and musa; and j) an oral dosage form orplurality of dosage forms comprising phytin, pyridoxine, and musa.
 3. Amethod of treating or inhibiting formation of kidney stones comprisingadministering to a patient in need thereof an oral dosage form or aplurality of dosage forms comprising three ingredients selected fromcitric acid, magnesium citrate, phytin, pyridoxine, and musa.
 4. Amethod of inhibiting growth of calcium oxalate crystals comprisingcontacting an aqueous solution comprising calcium oxalate with an oraldosage form or a plurality of dosage forms comprising three ingredientsselected from citric acid, magnesium citrate, phytin, pyridoxine, andmusa.